System, devices and methods for anatomically correct reconstruction of ligaments

ABSTRACT

A method, system and devices for the reconstruction of ribbon shaped ligaments following the anatomical native insertion sites of the ligaments in the corresponding bones is described. The reconstruction of the anterior cruciate ligament of the human knee is depicted. The system includes means for positioning and creating bone-tunnels, the preparation of grafts and the fixation thereof. The devices intended for bone tunnel creation take into account the ribbon-shaped nature of the ligament and can be adjusted to patient specific anatomy and take into consideration the various typologies of the ligament insertion sites. The method and devices for graft preparation are construed to reflect the anatomy of ligaments under consideration as close as possible to native ligaments by imitating the ribbon-like nature of native ligaments. The presented fixation methods follow this principle and are intended to support the ribbon-like nature of the grafts and are intended to support in-growth of the grafts. Furthermore, accessories supporting preparation of the grafts are presented.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. Ser. No.14/769,565, filed on Oct. 5, 2015, which is the National Stage ofInternational Application No. PCT/IB2014/000196, filed Feb. 24, 2014,which claims benefit under 35 USC § 119(a), to U.S. provisional patentapplication Ser. No. 61/767,816, filed Feb. 22, 2013.

FIELD OF THE INVENTION

The current invention relates to reconstruction of ribbon shapedligaments, in general, and more precisely to new methods, systems anddevices for a more naturally occurring anatomical reconstruction of thecruciate ligaments. By way of example, the reconstruction of theanterior cruciate ligament is described.

BACKGROUND OF THE INVENTION

The reconstruction of ligaments is necessary, when a ligament is tornand other measures to stabilize the affected joint do not showsufficient success. Among other joints, the knee is particularlyaffected. The anterior cruciate ligament (“ACL”) suffers the mostinjuries, predominantly among competitive athletes. ACL reconstructionsurgery is one of the most common types of orthopedic surgeries andapproximately 60,000-75,000 ACL reconstructions are performed annuallyin the United States, and many more worldwide.

Movements of the knee joint are determined by the shape of thearticulating surfaces of the tibia and femur and the orientation of thefour major ligaments of the knee joint: the anterior cruciate ligament(ACL) and posterior cruciate ligament (PCL) and the medial and lateralcollateral ligaments function as a four bar linkage biomechanicalmechanism. The principal function of the ACL is to resist anteriordisplacement of the tibia on the femur when the knee is flexed andcontrol the “screw home mechanism” of the tibia in terminal extension ofthe knee. Knee flexion/extension involves a combination of rolling andsliding which is called “femoral roll back.” This allows increasedranges of flexion. Asymmetry between the lateral and medial femoralcondyles permits the lateral condyle to roll a greater distance than themedial condyle during 20° of knee flexion. This causes coupled externalrotation of the tibia which has been described as the “screw-homemechanism” of the knee that locks the knee into extension. The ACLdrives this screw home mechanism, and absence of ACL control is thebasis of the pivot shift test of an ACL deficient knee.

A secondary function of the ACL is to resist varus rotation of thetibia, especially in the absence of the collateral ligaments.Additionally, the ACL resists internal rotation of the tibia. An ACLtear is most often sports-related, and results in knee joint instabilityand impaired biomechanical function. However, ACL tears also occurduring rough play, motor vehicle collisions, falls, and work-relatedinjuries. A high percentage of sports-related ACL tears are“non-contact” injuries. The injury occurs without the contact of anotherathlete, such as a tackle in rugby or football, or physical contactbetween basketball players. Most often ACL tears occur when an athletepivots or lands from a jump. The knee “gives-out” from under the athletewhen the ACL is torn and can no longer serve to biomechanicallystabilize the knee. Furthermore, female athletes are at a higher risk ofinjuring their ACL while participating in sporting activities than maleathletes.

High profile athletes very often have particular difficulty once theyhave sustained an ACL tear. Competitive sports, such as basketball,hockey, soccer, football and rugby require a fully biomechanicallyfunctioning ACL to perform maneuvers such as cutting, pivoting, andsudden turns. Periodic athletes may be able to function in their normaldaily activities without a normally biomechanically functioning ACL, butathletes engaging in high-demand sports have difficulty in doing so.Hence, athletes with ACL tears are often faced with the decision toundergo ACL reconstructive surgery in order to return to their previouslevel of performance.

DESCRIPTION OF THE RELATED ART

Anterior cruciate ligament (ACL) reconstructions are commonly performedby placing one or two bone tunnels at a tibial and femoral location ofthe torn ACL. By oblique drilling, oval bone tunnels at the tibial andfemoral locations are created. (Siebold et al., Restoration of thetibial ACL footprint area and geometry using the Modified Insertion SiteTable, Knee Surg Sports Traumatol Arthrosc., 2012 September;20(9):1845-9, the content of which is incorporated herein by reference).Various methods of ACL reconstruction have been proposed in the art. Byway of example, U.S. Pat. No. 6,723,524 describes: “A surgical implantfor securing ligament grafts into a joint. The implant is formedentirely of allograft cortical bone, and has a tapered tip with a sutureeye. A length of suture is knotted or looped through the eye. The sutureis used to draw the implant transversely through a looped graftconstruct to fix the graft by spanning a bone socket. The implant isused for knee ligament repair by forming a longitudinal socket in abone. A flexible strand is drawn with the pin through the bone. A loopedportion of the flexible strand is diverted so as to protrude out of theentrance to the longitudinal socket. The ends of the flexible strandremain accessible on either side of the bone. The ligament graft iscaptured within the strand loop protruding from the entrance to thesocket. The strand is retracted into the socket, drawing the graft intothe socket by pulling on the accessible ends of the flexible strand.”

Similarly, U.S. Pat. No. 5,374,269 also provides a method for ACLreconstruction. However, the art has several drawbacks, since it failsto take into consideration the native ACL insertion site to the femurand tibia and the shape of the ACL within the knee joint, and resultantbiomechanical functionality within a single joint and in relation to anun-injured native ACL joint. Anatomical dissections show, that the ACL,like other ligaments, resembles more a “ribbon-like structure” ratherthan an oval structure. The femoral insertion of the ACL has alongitudinal (8-18 mm) but narrow shape (3-5 mm). (Smigielski et al.,Ribbon anatomy of anterior cruciate ligament—part 1. Femoral attachmentand midsubstance (submitted for review), the content of which isincorporated by reference) Therefore, conventional oval bone tunneldrilling fails to reconstruct the natural anatomical shape of the nativeACL insertion site of the ACL attachment points on the femur, because inone direction the reconstruction is too narrow and in the otherdirection too wide to resemble natural anatomic conditions and two andthree dimensional structure, and provide for the naturally intendedstability and biomechanical function of the knee joint.

On the tibial side, anatomical dissections have shown, that theinsertion site of the ligament is not oval but appears rather“half-moon” or C-shaped. In some patient specific variations, theC-shaped insertion site is elongated on one end of the C, thereby havingan appearance of a more “J-shaped”insertion site. Siebold et al, TibialC-shaped insertion of the Anterior Cruciate Ligament withoutPosterolateral Bundle, Chapter of ESSKA Book: Anterior Cruciate LigamentReconstruction, DOI) 10.1007/978-3-642-45349_3, ESSKA 2014, the contentof which is hereby incorporated by reference. For the purposes of thisapplication, the meaning of the term “C-shaped” includes variations of aC-shape, but with the insertion site mimicking a native insertion site,in one variant of the invention.

As on the femoral side, the conventional bone tunnel drilling techniquedoes not reflect the native or natural anatomical situation on thetibial side. The natural anatomical reconstruction of the tibialinsertion is not possible with an oval bone tunnel. Furthermore, partsof the anterior root of the lateral meniscus may be damaged by theconventional technique.

Current methods aim to reconstruct the ligament by orientating the graftat the general prior location of the ligament while not considering thenatural footprint of the ACL at both tibial and femoral natural anchorpoints, while, in contrast, the method, devices and systems, here focuson the reconstruction of the insertion site of the ligament in the bonein a manner that substantially matches or mimics the natural ACL anchorpoint footprints on the tibia and the femur to obtain optimal anchorpoint configurations and biomechanical knee joint movement. This is afundamental distinction that solves a major problem in the art, sincethe naturally occurring tibial and femoral ACL anchor footprint does notnecessarily reflect the artificially made surgical insertion site, andtherefore the optimal and natural biomechanical anchor point of theligament. The present invention is further directed to solve thisproblem in the art, and does so. This is due to the fact, that—uponrupture of the ACL—not only the ligament, but also synovial and fattissue is dislocated from the bone, giving the perceived footprint ofthe ligament insertion site a broader and more distorted appearance thanin nature. For example, as shown by Smigielski et al., the ACL's fibersform a flat ribbon as close as 2 to 3 mm from its naturally occurringfemoral attachment point, while the respective footprint at this sitefalsely appears to be a broader and more cylindrical structure after ACLrupture.

In summary, conventional tibial and femoral bone tunnel drilling tools,systems and methods do not anatomically reconstruct the naturallyoccurring insertion sites of the ACL graft at points on the tibia andfemur that reflect the natural anchor point. The same holds true forligament reconstruction techniques in other parts of the body. Hence,there exists a need in the art for tools, systems and methods suitablefor the anatomical reconstruction of ribbon like ligaments and propergraft dimensioning and shaping in a ribbon like manner in the interiorof the knee joint and other joints as well as outside of joints thatconform to the natural anchor points of a native ACL on both the femurand the tibia post-reconstruction. The present invention salves theseand other problems in the art.

SUMMARY OF THE INVENTION

The invention provides a system for preparing a first and second bonefor a graft procedure. The system includes a device for creating on thefirst bone an entrance point mimicking a first native ligamentattachment footprint, the first native ligament insertion siteoptionally being a substantially half-moon shaped footprint. The devicehas an appliance for sequential drilling and/or burring of overlappingbores, which are arranged in a c-shaped manner to create or re-create asubstantially c-shaped insertion site.

The invention also includes a second device for creating on the secondbone an entrance point mimicking a second native ligament attachmentfootprint. The second native ligament attachment footprint optionallyhas a substantially slit shaped footprint, and the device has anappliance for sequential drilling and/or burring of overlapping bores.The bores are arranged in a substantially or perfectly slit-shapedmanner to create a slit-shaped insertion site. The slit-shaped insertionsite substantially conforms in size and cross-sectional dimension to acorresponding aperture created with the first device.

In another variant, the system includes and the method includes the useof a third device. The third device is selected from the groupconsisting of a device for creating a substantially ribbon-like ACLgraft (in which the graft has a first end and a second end), a devicehaving an appliance allowing to maintain the ribbon-like appearance ofthe graft by affixing parallel tendon bundles or affixing tendons whichare split and prepared in a way to give a flat, ribbon like appearance,and a device for affixing portions of a tendon which have been preparedto give a substantially flat and ribbon like appearance.

In yet another variant, the system includes and the method includes theuse of a fourth device for fixing at least a portion of the first end ofthe graft at a tibial anchor point. The fourth device has an appliancewhich allows affixing of a substantially flat graft to a flat orsubstantially flat structure on the fourth device by attaching the graftto the flat structure, the flat structure being constructed to beflexible enough to pass through a c-shaped bone tunnel.

In another variant, the invention provides a graft for ACLreconstruction. The graft includes a first portion which is shaped anddimensioned to substantially conform to a slit shaped bone entrancepoint. A second portion is shaped and dimensioned to be substantiallyribbon like, and a third portion that is shaped and dimensioned tosubstantially conform to a C-shaped bone entrance point.

In yet another variant, the system is used for creating a graft for ACLreconstruction and the system includes a device for making the graft.

The system and method is used for reconstructing a portion of a kneejoint with a torn anterior cruciate ligament using a graft. The grafthas a first end and a second end. It is appreciated that the naturallyoccurring attachment footprints of a native ACL are mimicked orreconstructed to provide biomechanical stability to the knee joint thatmatches or substantially matches the biomechanical stability provided bya native ACL. The system includes a first immobilizer that has abutton-like device attached to a flat structure. The first immobilizeris designed for positioning and use at a portion of the first end of thegraft in, or optionally on a femur, at least a portion of the graft isadapted for passing through a substantially slit shaped aperture on thefemur; and a second immobilizer having a flat structure attached to amechanism. The mechanism allows for and provides for immobilization ofthe attached graft by wedging and blocking of the attached fixationmeans, and the second immobilizer is constructed and used forpositioning and use at a portion of the second end of the graft in, oroptionally on a tibia, such that at least a portion of the graft isadapted to pass through a substantially C-shaped aperture on the tibia.

In another variant, the invention provides a method of reconstructing aknee joint with an anterior cruciate ligament tear using a graft. Thegraft has a first end and a second end. The method includes the stepsof: immobilizing a first end of the graft on a femur, at least a portionof the graft passing through a substantially slit shaped aperture on thefemur, immobilizing a second end of the graft on a tibia, at least aportion of the graft passing through a substantially C-shaped apertureon the tibia; and affixing the ends of the graft on their respectiveinsertion sites in a manner mimicking naturally occurring attachmentinsertion sites of a native ACL, in order to provide biomechanicalstability to the knee joint.

In another variant, the invention provides a method of providingsubstantially equal biomechanical stability for a bipedal mammal. Thebipedal mammal has a native ACL in a first knee joint and a torn ordamaged ACL in a second knee joint in the clinical setting. The methodincludes reconstructing the torn ACL in the second knee joint to obtaina reconstructed ACL. The reconstructed ACL includes a first portion of agraft passing through a substantially slit-like aperture in a firstbone, and a second portion of the graft passing through a substantiallyC-shaped aperture in a second bone; affixing the ends of the graft ontheir respective insertion sites in a manner mimicking naturallyoccurring attachment insertion sites of a native ACL, in order toprovide biomechanical stability to the knee joint; and, allowing forhealing with physiotherapy and supervised recovery, whereby thereafter,the biomechanical stability of the first knee joint is substantiallysimilar to the biomechanical stability of the second knee joint.

The invention further includes a method of providing substantially equalbiomechanical stability for a bipedal mammal having a native ACL in afirst knee joint and torn ACL in a second knee joint, whereby afterhealing, the biomechanical stability of the knee joints aresubstantially similar, the method comprising the steps of: forming agraft of an anatomically correct reconstructed ACL; forming an ACLfootprint mimicking a native ACL footprint in the second knee joint;passing a first portion of the graft that passes through a substantiallyslit-like aperture in a first bone; passing a second portion of thegraft through a substantially C-shaped aperture in a second bone;affixing the ends of the graft on their respective insertion sites in amanner mimicking naturally occurring attachment insertion sites of anative ACL, in order to provide biomechanical stability to the kneejoint; and allowing for healing with physiotherapy and supervisedrecovery, whereby thereafter, the biomechanical stability of the firstknee joint is substantially similar to the biomechanical stability ofthe second knee joint.

In yet another aspect, the invention includes a method of preparing atibia for an anatomically correct ACL reconstruction. The methodincludes cleaning and identifying a tibial native ACL footprint;measuring the tibial native ACL footprint with a template; locating andorienting a tibial insertion site; positioning a tibial aiming device;drilling a bone tunnel, or optionally a pocket, correlated to the nativetibial insertion site that has been cleaned and identified and being ina substantially C-shaped configuration; removing the tibial aimingdevice; and, optionally cleaning drilling edges.

In yet further variant, the invention provides a method of preparing afemur bone for an anatomically correct ACL reconstruction. The methodincludes the steps of: cleaning and identifying a femoral ACL footprint;measuring the native femoral ACL footprint with a template; locating andorienting a femoral insertion site; positioning a femoral aiming device;drilling a bone tunnel, or optionally a pocket, correlated with thenative femoral insertion site in a substantially slit shaped nativeconfiguration; removing the femoral aiming device; and optionallycleaning drilling edges.

The invention also provides a method of creating a tibial bone tunnelduring a ligament reconstruction surgery, comprising the steps of:cleaning and identifying a native tibial footprint; measuring a nativetibial footprint with a template; attaching or adjusting anintra-articular template to a tibial guiding device; attaching oradjusting a corresponding drill sleeve to the tibial guiding device;drilling to provide a guide-wire or a drill which stabilises the tibialguiding device; orienting the tibial guiding device; drilling adjacentbores or adjacent k-wires in case where a drill was set to stabilise thetibial guiding device; removing the tibial guiding device; drilling abore over the guide-wire or adjacent guide wires; and, optionallycleaning drilling edges.

In yet further variant, the invention provides a method of creating afemoral bone tunnel, comprising the steps of: cleaning and identifying anative femoral footprint; measuring a native femoral footprint with atemplate; introducing a k-wire with a stamping device with acorresponding femoral guiding device; setting the k-wire using an aimingtemplate and an arthroscope; drilling to provide a guide-wire or a drillwhich stabilises the femoral guiding device; orienting the femoralguiding device; drilling adjacent bores or adjacent k-wires in casewhere a drill was set to stabilise the femoral guiding device; removingthe femoral guiding device; drilling to a bore over the guide-wire; and,optionally cleaning drilling edges.

In yet another variant, the invention provides a method of preparing agraft for a ligament reconstruction procedure, comprising the steps of:harvesting a tendon; cleaning the tendon; arranging individual tendonstrands in a substantially ribbon-like, flat manner to mount and fixatethe tendon; and, preparing the individual tendon strands in a lineararrangement.

In yet further aspect, the invention provides a method of preparing agraft for a ligament reconstruction procedure, comprising the steps of:harvesting a tendon to obtain a round tendon structure; cleaning theround tendon structure; preparing a substantially flat, ribbon-likestructure from the round tendon structure along a longitudinal axis ofthe round tendon structure following tendon fibers, the substantiallyflat, ribbon-like structure having a first side and a second side;spanning the first side of the substantially flat, ribbon-like structuresubstantially orthogonally to the longitudinal axis of the substantiallyflat, ribbon-like structure by attaching the substantially flat,ribbon-like to an attachment structure; and, spanning the second side ofthe substantially flat, ribbon-like structure substantially orthogonallyto the longitudinal axis by attaching the substantially flat,ribbon-like to an attachment structure.

In yet further variant, the invention provides a method of preparing agraft for a reconstruction procedure, comprising the steps of:harvesting a tendon having a plurality of tendon strands; cleaning thetendon; providing a split-button device having a lower partition and anupper partition; introducing the tendon into the lower partition;introducing the tendon into the upper partition; providing a fiber-podhaving separate fields and loops; laying each tendon strand in aseparate field; weaving the plurality of tendon strands through theloops with a plurality of pull chords; tightening the tendon strands bypulling the pull chords; and, optionally securing the tendon strandswith sutures.

In another embodiment, the invention provides a method of preparing agraft for a procedure, comprising the steps of: harvesting a flat,ribbon-like portion of a tendon (e.g. patella or quadriceps tendon);cleaning the tendon portion; preparing a substantially flat tendonstructure; and attaching said structure to fixation means allowing theupholding of a flat appearance of the graft.

In yet further variant of the method, the invention provides a method ofreconstructing a ligament using a first bone tunnel and a second bonetunnel, comprising the steps of: creating the first bone tunnelaccording to and/or or corresponding to a first native ligamentinsertion site; creating a second bone tunnel according to and/orcorresponding to a second native ligament insertion site; preparing asubstantially ribbon-like, flat graft, the graft having a first end anda second end; pulling in the graft via the first bone tunnel into thesecond bone tunnel; fixing a portion of the first end of the graft inthe second bone tunnel; tightening and fastening the graft; and, fixinga portion of the second end of the graft in the first bone tunnel. Inthis variant of the method the first bone tunnel is a tibial bonetunnel, and the second bone tunnel is a femoral bone tunnel.

In another variant, a system, device and method are provided for thereconstruction of ligaments and more specifically for the anatomicallycorrect reconstruction of the anterior cruciate ligament (ACL).

It is an object of the invention to provide preparation, positioning andfixation devices for various grafts to create a ribbon like structurethat mimics a native ACL.

It is another object of the invention to provide methods for theanatomical reconstruction of ribbon like ligaments, especially theanterior cruciate ligament, to favour the delay of the onset ofarthrosis in the affected joint, which is a common consequence ofcurrent reconstruction techniques.

It is another object of the invention to provide tools used in thesystem and method for the creation of graft insertion sites of naturalACL anchor point sites (at the surface of the tibia and femur), whichhave a slit-like or substantially slit-like appearance to reconstructthe ACL in a ribbon-like fashion with straight and curved insertionsites at the femur and tibia, respectively, and thus mimic naturalbiomechanical ACL function and stability.

It is yet another object of the invention to create graft tunnels, whichincrease and favour bone graft interaction by providing as muchbone-graft interface as reasonably possible, which again favoursnutrition and in-growth of the graft, thereby reducing the risk ofre-rupture of the graft post procedure.

It is another object of the invention to provide means for fixing thegraft in the tibial and femoral tunnel, which allow enhanced bone-graftinteraction compared to current fixation methods.

It is a further object of the invention to provide tools adjustable tothe anatomic conditions of the patient for the accurate and simplelocation of the insertion sites.

It is another object of the invention to provide a tibial drill guide,which minimizes damage to parts of the anterior root of the lateralmeniscus, as opposed to current drilling methods, where these structuresmay be damaged more severely.

It is another object of the invention to provide a femoral drill guide,which allows direct visualisation of the femoral insertion site andavoids damage to the femoral condyle by supplying a drill-sleeve, whichcovers the drill as opposed to current drilling methods, where thesestructures may be damaged by drills touching the femoral condyle.

It is another object of the invention to provide graft preparationmeans, which allow a ribbon-like attachment of various grafts.

It is yet another object of the invention to split a roundtendon-structure into a ribbon-like structure that mimics a natural ACL,which resembles more the ribbon-like anatomy than current graftpreparation methods.

It is another object of the invention to provide graft preparation andfixation means, which allow the fixation of split-tendon grafts in thetibial and femoral tunnel.

It is another object of the invention to provide graft preparation andfixation means, which allow the fixation of flat tendon grafts harvestedfrom the patella tendon and the quadriceps tendon.

The present invention is directed to devices, systems and methods thatare also further described in the following Brief Description of theDrawings, the Drawings, the Detailed Description of the Invention, andthe claims. Other features and advantages of the present invention willbecome apparent from the following detailed description of the inventionmade with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an anatomical depiction of the ligament structure of theknee.

FIG. 1B is a side perspective view of the tibial insertion site of theACL with the arrows pointing to the insertion site.

FIG. 1C is a side perspective view of the femoral insertion site of theACL with the arrows pointing to the insertion site and the caliperillustrating the approximate length of the insertion site.

FIG. 2A is a perspective view of an assembled tibial aiming device, inwhich k-wires are used to stabilize a drill template.

FIG. 2B is a perspective view of the tibial aiming device without tibialdrill templates.

FIG. 2C is a perspective view of tibial drill templates and guide-wires.

FIG. 3A is a perspective view of a variation of an assembled tibialaiming device.

FIG. 3B is a perspective view of a variation of the tibial aiming devicewithout tibial drill templates.

FIG. 3C is a perspective view of a variation of tibial drill templates.

FIGS. 4A to 4C are plan views of exemplary bore configurations withtibial drill-sleeves.

FIG. 5A is a perspective view of a femoral aiming device.

FIG. 5B is a perspective view of a femoral aiming device with mountedarthroscope.

FIG. 5C is a perspective view of a femoral aiming device with mountedarthroscope and aiming aid for placing the guide-wire.

FIG. 5D is a perspective view of depth marks of a drill at the edge ofthe bore sleeve for measuring the depth of the bores before and duringdrilling.

FIGS. 6A to 6C are plan views of different bore-configurations with thefemoral drill-sleeves.

FIG. 7A is a perspective view of the device for femoral tendonattachment and fixation for a quadruple graft.

FIG. 7B are perspective views of a sling and button for femoral tendonattachment and fixation with flexible window partitioning.

FIG. 7C are perspective views of a sling and button for femoral tendonattachment and fixation wherein the partitioning is a bar that can movealong the sling or loop.

FIG. 7D is a perspective view of a sling and button for femoral tendonattachment and fixation with an inserted quadruple graft.

FIG. 8A is a perspective view of a device for tibial tendon attachmentand preparation using a quadruple graft.

FIG. 8B is a perspective view of the backside of the device with anempty slit.

FIG. 8C is a perspective view of the backside of the device with a slitcontaining a cord.

FIG. 8D is a perspective view of the loops of the cord.

FIG. 8E is a perspective view of the device for tibial tendon attachmentusing a quadruple graft, with the tendon in place.

FIGS. 8F-8I are progressive views showing tibial tendonpreparation/attachment.

FIG. 9A to FIG. 9D show four different examples of devices forextra-osseous fixation of the tendon graft, which is attached to twocords or sutures; each FIG. 9A to 9D example depicting an alternateembodiment of the device.

FIG. 10A is a perspective view for an extra-osseous fixation device inits open state,

FIG. 10B shows a perspective view for an extra-osseous fixation devicein its closed state. Upper drawing depicts an exploded perspective viewof the device.

FIG. 10C is a top view of open (left) versus locked (right) device.

FIG. 10D is a cross section of open (left) versus locked (right) device.

FIG. 10E is a bottom view of open (left) versus locked (right) device

FIG. 11 are perspective views of a device for extra-osseous fixation ofthe tendon graft, where the knot of the cords can be hidden in acountersink in the device.

FIG. 12A is a perspective view of a device for splitting a round tendoninto a ribbon-like structure.

FIG. 12B is a detail view of a device FIG. 12A, in which the roundtendon is split by a scalpel as shown.

FIG. 12C is a perspective view of an alternate embodiment of a devicefor splitting a round tendon into a ribbon-like structure.

FIG. 13A is a perspective view of the device for femoral tendonattachment and fixation using a ribbon-like tendon graft.

FIG. 13B is a perspective view of bent tape for easier introduction inthe tibial and femoral tunnel.

FIG. 13C are perspective views of various alternate embodiments of theelement which holds the tendon.

FIG. 13D are perspective views of various mesh layers bent over the cordof the embodiments.

FIG. 14A is a perspective view of an assembled device for tibial tendonattachment and fixation using a ribbon-like tendon graft.

FIG. 14B are perspective views of the fixing device for tibial tendonfixation using a ribbon-like tendon graft (extra-osseous element).

FIG. 14C is a plan view of the element for tendon attachment.

FIG. 14D are progressive views depicting the process for fastening theelement for tendon attachment to the fixation device.

FIG. 15A is a top view of the femoral aiming aid.

FIG. 15B is a perspective view of the femoral aiming aid.

FIG. 15C is a perspective view of the tip of the femoral aiming aid.

FIG. 15D is a perspective view of the femoral aiming aid aligned with alongitudinal cut of the femur.

FIG. 16A is a top view of a device for calibrated tensioning of a graftattached to two cords (device not drawn to scale).

FIG. 16B is a perspective view (surgeon's view) of a device forcalibrated tensioning of a graft attached to two cords.

FIGS. 17A and B are flowcharts depicting a generic method foranatomically correct reconstruction of a ligament structure employingC-shaped and slit-like bore tunnels.

FIGS. 18A and B are flowcharts depicting a method for anatomicallycorrect reconstruction of a ligament structure employing C-shaped andslit-like bore tunnels.

FIGS. 19A and B are flowcharts depicting generic methods for thepreparation of flat, ribbon-like grafts from multiple parallel bundlesor from split tendons.

FIGS. 20A and B are flowcharts depicting the methods for creating aribbon-like ACL graft from either multiple parallel bundles or from atendon, which is split to form a ribbon-like structure.

FIG. 20C is a flowchart depicting the method for inserting, tensioningand fixing a ribbon-like graft for anatomical ACL reconstruction

FIG. 21A is a photograph depicting a ribbon-like graft made from amultiple tendon bundle.

FIG. 21B is a photograph depicting a ribbon-like graft made from a splittendon.

FIG. 22A is a perspective view of the tibial dilator.

FIG. 22B is another perspective view of the backside of the tibialdilator (with inserted k-wires).

FIG. 22C is a detail of the “head” of the tibial dilator.

FIG. 22D is a top view of the “head” of the tibial dilator with insertedk-wires.

FIG. 23A is a perspective view of the femoral dilator.

FIG. 23B is a detail of the “head” of the femoral dilator.

FIG. 23C is a detail of the “head” of the femoral dilator with insertedk-wire.

FIG. 23D is a top view of the “head” of the femoral dilator.

FIG. 24 illustrates an overall system view with exemplary system devicesdescribed herein, and in which a plurality of the system devicesdescribed herein are used in various combinations.

Those skilled in the art will appreciate that elements in the figuresare illustrated for simplicity and clarity and have not necessarily beendrawn to scale. For example, dimensions may be exaggerated relative toother elements to help improve understanding of the invention and itsembodiments. Furthermore, when the terms ‘first’, ‘second’, and the likeare used herein, their use is intended to distinguish between similarelements and not necessarily for describing a sequential orchronological order. Moreover, relative terms like ‘front’, ‘back’,‘top’ and ‘bottom’, and the like in the figures, Description and/or inthe claims are not necessarily used for describing exclusive relativeposition. Those skilled in the art will therefore understand that suchterms may be interchangeable with other terms, and that the embodimentsdescribed herein are capable of operating in other orientations thanthose explicitly illustrated or otherwise described.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description is not intended to limit the scope of theinvention in any way as it is exemplary in nature, serving to describethe best mode of the invention known to the inventors as of the filingdate hereof. Consequently, changes may be made in the arrangement and/orfunction of any of the elements described in the exemplary embodimentsdisclosed herein without departing from the spirit and scope of theinvention.

In the following description, complete methods, devices and systems forligament reconstruction, especially of the anterior cruciate ligamentand its use are described. The systems comprise aiming devices forcreating the tibial and femoral tunnels, devices for graft preparationand fixation, as well as accessories to achieve the reconstruction ofligaments that mimic the natural ACL in biomechanical shape, functionand anchoring to the tibia and femur.

The method further includes repairing a knee joint with anteriorcruciate ligament damage with a graft. The graft has a first end and asecond end. The method includes immobilizing a first end of the graft ona femur such that at least a portion of the graft passes through asubstantially slit shaped aperture on the femur; and, immobilizing thesecond end of the graft on a tibia such that at least a portion of thegraft passes through a substantially C-shaped aperture on the tibia. Itis appreciated that the naturally occurring attachment insertion sitesof a native ACL are mimicked to provide biomechanical stability to theknee joint. It is also appreciated that the method and system providedherein aim at providing substantially similar naturally occurringbiomechanical stability between the damaged knee joint as compared to anundamaged knee joint with a native ACL. Moreover, it is appreciated thatthe biomechanical stability within the repaired knee joint is returnedto a substantially pre-injury biomechanical stability, particularly withrespect to the ACL interaction between the posterior cruciate ligaments(PCL). Having substantially similar biomechanical stability between anuninjured knee joint and the reconstructed knee joint post ACLreconstruction, and within the reconstructed knee is highly desirable,especially among professional athletes.

As such, a method of preparing for a surgery to provide substantiallyequal biomechanical stability for a bipedal mammal is also includedherein. The bipedal mammal (of course, other quadra-pedal mammals canbenefit from the methods and systems of the invention, in othervariants) having a native ACL in a first knee joint and a torn ACL in asecond knee joint. The method includes providing one or more of thedevices described herein to create an anatomically correct reconstructedACL in the second knee joint. The anatomically correct reconstructed ACLincludes a first portion of a graft passing through a substantiallyslit-like aperture in a first bone, and a second portion of the graftpassing through a substantially C-shaped aperture in a second bone suchthat the biomechanical stability of the first knee joint issubstantially similar to the biomechanical stability of the un-injuredsecond knee joint.

With this in mind, a system for preparing a first and second bone for agraft procedure is also described herein. The system includes a devicefor creating on the first bone an entrance point having a substantiallyhalf-moon shaped footprint, and a device for creating on the second bonean entrance point having a substantially slit shaped footprint. While itis appreciated that the method and system herein is described for ACLreconstruction, it can be used on other ligaments in the body.

Where the method, device and system of the invention is applied todamaged ligaments in joints other than the knee joint, the anatomicalattachment sites of the native ligaments are substantially matched tothe reconstructed ligaments with corresponding apertures and insertionsites created in the respective bones so that biomechanicalfunctionality is mimicked to the native ligament, as well as betweenjoints on corresponding un-damaged limbs.

Anatomy

Referring to FIG. 1A, the native, natural anatomy of the ligamentstructures within the knee is shown, with special focus on the anteriorcruciate ligament (front). In FIG. 1B, the tibial plateau is shown withthe tibial insertion site of the anterior cruciate ligament (indicatedwith arrows). Note the curved (C-shaped) nature of the tibial insertionsite 1000 as indicated by the black arrows. The native C-shaped crosssection of the tibial insertion site 1000 is identified, and created bythe devices, system and method(s) described herein on the tibial plateauor plane. The tibial insertion site 1000, created by the method(s),devices(s) and system, has a substantially planar two-dimensional crosssection that is substantially C-shaped as in nature. The inner wallscreated by the device(s), method and system of the tibial insertion site1000 are substantially smooth so as not to have rough edges that coulddamage the new, prosthetic ligament that will be resident in theaperture formed by the inner walls and tunnel through the tibia.Referring now to FIG. 1C, the femoral insertion site 1102 of theanterior cruciate ligament (marked with arrows 1100) is shown. Note theflat and ribbon-like nature of the femoral ligament insertion site 1102.Similarly, the inner walls created by the device(s), method and systemof the femoral insertion site 1000 are substantially smooth so as not tohave rough edges that could damage the new, prosthetic ligament thatwill be resident in the aperture formed by the inner walls and tunnelthrough the femur. The femoral insertion site 1102, created by themethod(s), devices(s) and system, has a substantially planartwo-dimensional cross section that is substantially slit-shaped as innature.

The system, devices and method presented here are intended to allowreconstruction of these ligament structures in a manner that mimics orsubstantially matches the naturally occurring anatomical ACL inconformation, shape and anchor point attachment design as closely asreasonable possible to the natural or native structures and geometricconformation, e.g. two dimensional geometric conformation and also threedimensional conformation. As opposed to current methods, especially theflat and ribbon shaped nature of the ligament at the insertion sites canbe reconstructed with great ease.

The system comprises devices (FIGS. 2A-15D, 16A-16-B, 21A-B, and22A-22D) and methods (FIGS. 17A-20C) for the creation of the tibial andfemoral insertion sites as well as mounting of the prosthetic ligaments,both adapted to the individual, specific anatomy of the patient. It isappreciated that native ligament footprints vary from patient topatient, and that, in one variant of the invention, the one or more boneapertures or tunnels created in the method illustrated (FIG. 20C) aredesigned to be customized in size for a respective patient. By way offurther example, the bone apertures or tunnels in the damaged knee arecreated to match or substantially match the ligament attachmentfootprints 1002, 1102 (FIGS. 1B-1C) that are in an un-damaged knee. Thebone apertures or tunnels are created with system 3000 tools 200, 200′,300 (FIGS. 2A-5D), drills (not shown), burrs (not shown), templates,4003-4005 (FIGS. 4A-4D), 6004-6006 (FIGS. 6A-6D), and other accessoriesdescribed herein.

The system 3000 (FIG. 24) further includes tools 500 (FIGS. 8A-8I), 550′(FIG. 10A-10E, FIG. 11) 600, 600′ (FIGS. 12A-12C) for the preparation ofribbon-like ligaments from multiple tendon bundles or from split tendonsthat also mimic native ligament structure and function as well aspositioning in the damaged joint. The system 3000 comprises tools (FIGS.2A-15D, 16A-16-B, 21A-B, and 22A-22D) designed for the preparation andsimple fixation of both kinds of ribbon-like grafts at the tibial andfemoral insertion sites. The use of these devices for the anatomicalreconstruction of the ACL is discussed in detail below. Of course,system 3000 includes other tools that are used to enable the system andmethod described herein that are known to surgeons with expertise inreconstruction procedures.

Device for Creating the Tibial Insertion Site.

Referring to FIGS. 2A-2C, tibial aiming device 200 is presented, whichallows precise positioning and creation of a C-shaped tibial tunnel (notshown) by multiple position and anatomical location drilling techniquesand procedures at footprints 1002, 1102. The fully assembled device 200is shown in FIG. 2A, while FIG. 2B depicts the parts, 201-214 which arepreferably made from stainless steel, although other metals can also beused that are used for surgical tools. FIG. 2C finally comprises parts206, 211, 213), which are chosen according to the anatomy of a patient'sinsertion site. Device 200 consists of an intra-articular 201 and anextra-articular part 202, which are connected via an arc 205 or asimilar structure.

The patient specific, custom sized and dimensioned parts of FIG. 2Ccomprise the intra-articular template 206 which fits into frame 203 ofthe intra-articular part 201, as well as the correspondingextra-articular drill sleeve 207 fitting into the drill-sleeve mounting214. The intra-articular template 206 can be chosen according to theanatomy of the insertion site of the patient. Alternatively, theintra-articular template can be fixed (permanently or removable) to arc205 without the use of frame 203 by using other means of fixation (e.g.slits, etc.). By using the corresponding drill sleeve 207, a drilltunnel is created at insertion sites, which reproduces the tibialinsertion site 1002 according to the principles of the invention.

Once the tibial plateau (FIG. 1B) has been cleaned from residuals of thetorn ACL (not shown) and the insertion site 1002 has been laid open(FIG. 1B), a tibial intra-articular template 206 can be chosen from aset of different templates according to size and shape of the insertionsite to create the desired substantially half-moon or fully half-moonfootprint on the tibial plateau. In another variant of the invention,the footprint is a curve or an arch or a linear slit, as required. As aresult, the corresponding extra-articular drill-sleeve 207 is defined aswell. Template and corresponding drill-sleeve are then introduced intoframe 203 of the intra-articular template mounting 201 and theextra-articular drill-sleeve mounting 214, respectively. Theintra-articular template 206 is positioned over the tibial plateau insuch a way, that the opening 213 in the template corresponds to theC-shaped tibial insertion site on the tibial plateau.

Pin 212 on the intra-articular part 201 and guide wires 211 mounted ondrill sleeve 207 of the extra-articular part 202 are used to fix thetibial aiming device 200 to the tibia. This can be accomplished bypushing the guide wires towards the tibia, by means of which pin 212 andguide wires 211 will be indented in the intra-articular and theextra-articular parts of the tibia, respectively.

Therefore guide-wires 211 are introduced in the slotted holes 210 of thedrill-sleeve 207 and thereby slightly compressed in order to remainfixed unless pushed further in by the surgeon. They can be moved alongthese holes until they reach the tibia and are anchored within. Byfastening screw 204 or similar locking device, the drill-sleeve 207 iscompressed and with it the slotted holes 210. Thereby guide-wires 211and drill-sleeve 207 are simultaneously fixed in drill sleeve mounting214.

Alternatively, the drill-sleeve itself contains protrusions, spikes orthe like which aid in the fixation of the drill sleeve to the tibia (notshown).

In FIGS. 3A to 3C, variation 200′ of tibial aiming device 200 (FIGS.2A-C) is shown. Here, fixing of the aiming device 200′ to the tibia isaccomplished by pins 211′ (or similar structures), which are attacheddirectly to the drill sleeve mounting 214. These pins 211′ can be movedlongitudinally together with the drill sleeve mounting, fulfilling thesame role as guide-wires 211′, except that they cannot be individuallyadjusted to the patient specific geometry of the tibia. As analternative to fixed guide wires 211′ on drill-sleeve mounting 214, thedrill sleeve mounting itself contains protrusions, spikes or the likewhich aid in the fixation of the drill sleeve to the tibia (not shown).

Guide wire tube 208′ (FIG. 3C) allows a guide wire to be driven to thetibial plateau from outside, after the tibial aiming device has beenfixed to the tibia. Consecutively, a plurality of bores (in the shownembodiment two) are made by applying drills through drill tunnels 209′of drill sleeve 207′. The tibial aiming device can then be removed whilethe guide-wire, still being kept in place, is over drilled with a hollowdrill. Since the drill bores overlap (overlapping drill bores), a slitis created, which corresponds to the intra-articular template 206′ andthe tibial insertion site of the ACL, respectively. Cleaning andsmoothing of bore edges can be performed optionally by using a drill,bur, rasp, chisel, knife or a similar device.

Alternatively, dilators (not shown), which are of same size and shapelike the intended c-shaped tunnel, can be used to compress or dislocateremaining bone structures to achieve the intended smooth surface grafttunnels.

Referring now to FIGS. 4A-4C, different bore-configurations 4000-4002(first row) with the corresponding tibial drill-sleeves 4003-4005(second row) are depicted. As shown in FIG. 4A the guide-wire 4007(indicated as a bold circle) can be in the middle of the two adjacentdrill tunnels 4009, 4010. The corresponding drill sleeve has a guidetube for the guide-wire in the center and after setting the guide-wire,the drill sleeve can be adjusted by rotating around the guide wire(depicted in last row, angle α). Another bore configuration is shown inFIG. 4B, where the guiding tube 4013 for the guide-wire (indicated as abold circle) is placed off-center and the adjacent drill tunnelsoverlap. With this configuration, where the drill tunnels 4011, 4012 arecloser together, smaller and shorter slits can be generated. Aftersetting the guide-wire, adjustment of the final bores can be made bytilting the drill-sleeve around the guide-wire (indicated as angle β).In another configuration (FIG. 4C), the drill sleeve 4005 is fixed bydrilling in two guide-wires 4014, 4015 in the lateral guide-wire tubes,followed by drilling the central bore 4016. After drilling, the tibialaiming device is removed

The guide-wires, which are still in place, can then be over drilled witha hollow drill. No adjustment of the drill sleeve is possible aftersetting of the guide-wires here.

Since the guide wire(s) should not be removed before over-drilling, thedevice is designed in a way, that drill-sleeve 207 and drill sleevemounting 214 can be detached from frame 203 without dislodging the setk-wire (s). In the shown embodiment, this is accomplished by a design,where drill sleeve mounting 214 and drill sleeve 207 are unlocked fromframe 203 and pulled from the guide-wires.

Alternatively, employing the configuration in FIG. 4C, the tibial drillsleeve 4005 can be fixed to the tibia by drilling via the central borechannel 4016 and leaving the drill in the drill hole. The drillstabilizes the drill sleeve 4005 and consecutively (here, by way ofexample 2) k-wires are drilled through the adjacent k-wire channels.After removing drill sleeve 4005 and drill (not shown), the k-wires areover-drilled, resulting in overlapping bore channels. Of course, it isappreciated that a plurality of k-wire channels and bore channels can beused in various embodiments of the invention, positioned in relation toone another so as to obtain the desired conformation of a respectiveinsertion site.

Device for Creating the Femoral Insertion Site

In FIGS. 5A-5D, femoral aiming device 300 is presented, which aids inprecise positioning and creation of the femoral tunnel resembling thefemoral insertion site 1100, which is slit shaped or substantially slitshaped. As shown in FIG. 1C, the femoral insertion site 1102 is astraight slit or substantially straight slit with individual patientspecific variations in width and length, e.g. two dimensional crosssection. It is appreciated that the insertion sites described herein,create a patient specific, naturally occurring insertion site for thereconstructed ACL.

As depicted in FIG. 5A, femoral aiming device 300 consists of handle 301attached to guiding sleeve 302 with guiding tube 303 for guide wire 305and adjacent channels 304 for the drill(s). In the present embodimentguiding sleeve 302 contains two drill channels 304. Femoral aimingdevice 300 may, however, contain just one or more than two drillchannels 304, e.g. a plurality of drill tunnels. As shown in FIG. 5B,the femoral aiming device 300 can be equipped with an optionalarthroscope 307 to enable direct visualization of the femoral insertionsite 1100 and interior of the knee joint. Arthroscope 307 can forexample be introduced through a drill channel 304 or any other port (notshown) located nearby. In another embodiment (FIG. 5A and FIG. 5C)guiding tube 302 has openings 312 at the side walls of the tip of theguiding tube, which allow lateral vision of the surgeon to the femoralinsertion site 1100.

As exemplified in FIG. 5C the femoral aiming device 300 can be furtherequipped with a guide wire 305, holding “stamping” device 306 on itsdistal end. This stamping device is used to allow a first fixation ofthe guide wire to the femoral insertion site 1100 by pushing the guidewire into the intra-articular cortex of the femur.

The assembled femoral aiming device (as shown in FIG. 5C) is introducedlaterally under direct visualisation employing the arthroscope 307. Byusing an appropriate arthroscope 307, the guide wire and the femoralinsertion site 1100 can both be visualized simultaneously. Positioningof guide wire 305 is furthermore facilitated by guiding device 900depicted in FIGS. 15A-15D. Once the guide wire is placed in the centerof the insertion site, it is fixed by tapping or pushing the “stamping”device 306. Subsequently, stamping device 306 and arthroscope 307 areremoved and the guide wire is drilled to the posterior cortex of thefemur. Bores (two in the shown embodiment comprising two drill channelsor more bores involving a plurality of drill tunnels, although a largernumber of bores than two are also contemplated in other variants of theinvention) are made by drill 310 guided by drill channels 304 adjacentto the channel holding the guide wire. The depth of the bores can becontrolled by reading the depth marks 311 on drill 310 before and duringdrilling (as detailed in FIG. 5D). As such is it appreciated that thedevices, system 3000, and methods described herein provide for variabledepth bore holes and limit stops on the devices to control the depth ofthe drilling. With the help of these depth marks 311, the device 300 canbe used to perform drilling through the whole bone to form a uniformtunnel, or it can just be used to create a pocket in the bone or therespective femoral footprints described herein.

After drilling the bores adjacent to the guide wire, the femoral aimingdevice 300 is removed. The guide-wire, which is still in place, can thenbe over drilled with a cannulated drill. Since the drill bores overlap,a slit is created, which corresponds to the femoral insertion site 1100of the ACL (as depicted in FIG. 1C). Cleaning and smoothing of the boreedges can be performed optionally by using a drill, bur, rasp, chisel,knife or a similar device. Alternatively, dilators, which are of samesize, dimensional conformation, e.g. 2 dimensional or 3 dimensional, andshape as the intended femoral tunnel, can be used to compress ordislocate remaining bone structures to achieve the intended graftchannels (refer to FIG. 23A to 23D).

In FIGS. 6A-6C, different bore-configurations 6000-6002 (first row) withthe according femoral drill-sleeves 6004-6006 (second row) are depicted.As shown in FIG. 6A, the guide-wire 6007 (indicated as bold circle) canbe in the middle of the two adjacent drill tunnels 6008, 6009. Thecorresponding drill sleeve has a guide tube 6010 for the guide-wire inthe center and after setting the guide-wire, the drill sleeve can beadjusted by rotating around the guide-wire (depicted in last row, angleα). Another bore configuration is shown in FIG. 6B, where the guidingtube for the guide-wire (indicated as bold circle) is placed off-centerand the adjacent drill tunnels 6012, 6013 overlap. With thisconfiguration, where the drill tunnels 6012, 6013 are closer together,shorter slits can be generated. After setting the guide-wire, adjustmentof the final bores can be made by tilting the drill-sleeve around theguide-wire (indicated as angle β).

In another configuration (FIG. 6C), the drill sleeve is fixed bydrilling in two guide-wires in the lateral guide-wire tubes, followed bydrilling the central bore. After drilling, the femoral aiming device isremoved. The guide-wires, which are still in place, can then be overdrilled with a hollow drill. No adjustment of the drill sleeve ispossible after setting of the guide-wires here. Alternatively, employingconfiguration 6C, the femoral drill sleeve can be fixed to the tibia bydrilling via the central bore channel 6014 and leaving the drill in thedrill hole. The drill stabilizes the drill sleeve and consecutively(here 2) k-wires are drilled through the adjacent k-wire channels 6015,6016. After removing drill sleeve and drill, k-wires are over-drilled,resulting in overlapping bore channels

Devices for Graft Preparation and Fixation Using Multiple Tendon Bundles

The devices 400, discussed in the following two sections allow for thepreparation and fixation of a tendon graft using multiple tendonbundles. These bundles are aligned in a linear manner to resemble theribbon-like nature of the ligament. As an example, the preparation andfixation of a quadruple graft will be shown.

1) Device for Graft Preparation and Fixation at the Femoral Side of theMulti-Bundle Graft

In FIG. 7A, device 400 for femoral tendon attachment and fixation usinga quadruple graft is depicted. The device 400 is button-like withelongated body 407, holding sling or loop 401, which is subdivided by atleast one partitioning. The fixation of the sling or loop 401 to theelongated body 407 may be accomplished either by passing loop 408, 428through holes in the elongated body or by fixing the ends of loop- orsling-structure 401 to the elongated body by other means (see detail411, 421). The partitioning can either be a flexible structure 405 or abar-like element 425. This partitioning results in at least two“windows” 402, 404, through which the tendon graft is introduced. Thepartitioning 405 can be either fixed (FIG. 7A, B) or may move alongsling or loop 401, as exemplified by bar 425 in FIG. 7C.

The elongated body has furthermore two openings 403, 406 through whichpulling cord 409 and a tilting cord 410 can be introduced. Once thetendon (not shown) is attached to the loop or sling structure 401, theelongated body 407 of the button-like device 400 can be pulled through abone tunnel, until it exits at the extra-osseous side of the bone. Bypulling at the tilting cord, the button flips into a positionperpendicular to the bore and is thus secured at the extra-osseous sideof the bone. A more detailed description of the mode of action may befound in U.S. Pat. No. 5,306,301 to Graf, the entire disclosure of whichis hereby incorporated by reference. In contrast to the device presentedby Graf et al. in U.S. Pat. No. 5,306,301, device 400 features rigid orflexible partitioning of the loop or sling structure.

In FIG. 7D, a first tendon bundle 421 introduced in lower window 404 anda second bundle 420 in higher window 402 remains separated bypartitioning 405, 425. Pushing together of the individual tendon strandsis thus avoided by the partitioning. Consecutively, the strands of thetendons form a linear alignment, where the lower strand of the tendonholds the upper strand apart. This method allows a ribbon-likearrangement of the individual tendon bundles. They can still be bent inthe transverse direction, which is especially important, when the grafthas to be passed through a curved (e.g. C-shaped) tunnel.

Furthermore, pushing together of the individual bundles is hindered bythe sequential entry of higher 420 and lower 421 tendon strands into thetibial and femoral tunnel. This sequential entry furthermore eases thepulling in of the tendon. This is especially important for cases inwhich narrow, slit-like tunnels are employed.

2) Device for Graft Preparation at the Tibial Side of the Multi-BundleGraft

In FIG. 8A, a device 500 for tibial tendon attachment and preparationusing a multi-bundle graft is depicted. Exemplary the attachment andpreparation of a quadruple graft is shown. The device 500 consists ofbase plate 504 with holes 505, which are connected by slits 506. Thesize of holes 505 is sufficiently large to let cord or suture material501, 502 pass through. Slits 506 are, however, narrower and allowpassing of cord 501, 502 only when it is under a sufficient tensileforce, such that the slits are somewhat widened when pulled therethrough. FIG. 8B details the backside of base plate 504 with holes 505and slits 506 but without the cord. As depicted, the slit is wider onthe backside of base plate 504 which is thin enough to allow the cord topass when it is subject to a sufficiently high tensile force.

FIG. 8C shows the backside of base plate 504 in the presence of cord501, 502. On the backside the slit is somewhat wider than on the front,forming channels 507 wide enough to accept the cord. The cord is thusheld in channels 507 but cannot pass slits 506 unless subject to asufficiently high tensile force. Referring now to FIG. 8D, a detailedview of base plate 504 in the presence of the cord is shown. The cord isintroduced in the following sequence. Coming from the upper side of thebase plate its left pulling end 501 is fed through hole1. The cordsegment between holes 1 and 2 lies in channel 507 on the backside of thebase plate. The cord is fed through hole 2 to the front side of the baseplate and then back again through hole 3 thus forming loop 503. Thesegment between holes 3 and 4 lies again in channel 507 on the backsideof the base plate, and so on. With this procedure, a structure iscreated, where pulling ends 501, 502 of the cord as well as loops 503are on the front side of the base plate, while the connecting sectionsof the cord are on the backside of the base plate.

The illustration of FIG. 8A shows an embodiment with 3 loops 503 for thepreparation of 4 individual (tendon-) bundles. Other embodiments of theinvention comprise a plurality of bundles, e.g. greater or lessernumbers of bundles with a correspondingly varying number of loops 503.Referring now to the sequence of FIGS. 8E to 8I, the formation of aribbon-like tendon is shown by making use of base plate 504 with cord501, 502 arranged in loops 503. In a first step, the four strands of thetendon are arranged in the manner shown in FIG. 8E, in which everystrand is separated by a loop. In a second step detailed in FIG. 8F, theleft pulling end 501 of the cord is folded over and fed above the tendonthrough loops 503 to the right side. Meanwhile, the right pulling end502 is passed in the opposite direction over the tendon through theloops to the left side. By pulling ends 501 and 502 of the cord, theloops are pulled towards the base plate and the tendon (FIG. 8G). Byfurther pulling, the tendon is compressed and thereby fixed (FIG. 8H).Finally, under the application of a sufficiently high tensile force, thecord slips through slits 506 of the base plate and the lineartendon/cord construct is released from the same (FIG. 8I). The resultingstructure can be further secured by “weaving” the ends of the pullingcords above and under the individual strands of the tendon or bystitching the pulling cords through the tendon from the left to theright side and vice versa.

With this procedure, a linear mounting for the tibial side of amulti-bundle graft is formed, where the individual strands are pressedtogether, but cannot slip over each other, thereby avoiding a bulkygraft to form. This is especially important in the case where slit-liketunnels with a small width are employed. Another advantage over othergraft preparation methods is, that the bone tendon interface is as bigas possible and that the prepared graft can be bent, which is especiallyimportant, when bone tunnels with bent (e.g. C-Shaped) cross sectionsare used for graft insertion.

3) Device 1 for Tibial Fixation of the Multi-Bundle Graft

The prepared tendon graft has to be secured at the exit of the tibialtunnel. This cart be achieved by an extra-osseous element[[s]] 510′,520′, 530′ and/or 540′, which fixes the cords coming from the graft.Usually two cords are used, which can but need not be identical topulling ends 501, 502, but the devices shown below can also be adaptedto usage of more cords. Referring now to FIGS. 9A-9D, a series ofembodiments of a device 510′, 520′, 530′ and/or 540′ for extra-osseousfixation of the tendon graft is shown. The graft is attached to two (ormore) cords or sutures. Referring now to FIG. 9A, device 510′ has a flatrigid body 550, which is bigger or larger than the created bone tunnelsand has two openings 551, 552 to accept the cords attached to the graft.The cords are passed through openings 551, 552 and the graft can befixed by tying the cords in a knot. Referring now to FIG. 9B, device520′ has depression 563 in flat rigid body 560. Depression 563 has thepurpose of accepting the knot tied between the cords fed throughopenings 561, 562. The protrusion of the knot into the soft tissuesurrounding the bone is therefore minimized. Referring now to FIG. 9C,device 530′ has non-circular openings 571, 572 with narrow regions 573,574 facing the center of the device. This results in wedging of thecords before the knot is tied, preventing loosening of the tensionapplied to the graft during tying of the knot.

In FIG. 9D, device 540′ has flat rigid body 580 featuring slopedextension 585 at the far side of the graft. Furthermore, body 580 withits sloped extension 585 features two slits 586, through which the cordsare fed. Then the cords are secured by making knots on each individualcord at position 587 close to the rise of sloped extension 585. Theknots are made large enough in order not to pass slits 586. Afterknotting, the cords can be further tensioned by pulling them over theslope of sloped extension 585 to securing position 584 more distant fromthe graft.

4) Device 2 for Tibial Fixation of the Multi-Bundle Graft

Referring now to FIGS. 10A-10E, device 550′ fixes the two cords comingfrom the graft by wedging them between an inner turning member and itscorresponding casing. Base plate 523 is large enough to bridge the boresof the tunnel. It holds the casing/sleeve 522 for central fasteningmember 519, which can be rotated around its central axis. Furthermore,the device features two openings 528, 529, shared by sleeve 522 andfastening member 519. Openings 528, 529 allow feeding of the two cordsfrom the intra-osseous side 521 to the extra-osseous side 520 in itsopen or unlocked position. By turning fastening member 519 the cords canbe locked by wedging them between sleeve 522 and the fastening member aswill now be explained in greater detail.

In FIG. 10A, a perspective view of the device is shown in its open statein which the cords can pass through openings 528, 529. In FIG. 10B; aperspective view of the device in its closed state is shown (below). Theupper drawing of FIG. 10B depicts an exploded perspective view of thedevice. The body of fastening member 519 has a jagged appearance 537resembling the threads of a screw with cut outs 534 of preferablyhalf-cylindrical shape, corresponding to openings 528, 529. The cordsare fixed by turning inner fastening member 519 relative to outer sleeve522. Rotation of the inner fastening member results in displacing itscut outs from the openings in the sleeve, whereby the cords arecompressed between the jagged inner fastening member and wall 533 ofsleeve 522. Preferably, the angle of rotation is chosen in a way toalign the extra-osseous side 520 of the cords with grooves 525 onfastening member 519. As shown below (FIG. 11), this facilitates minimalprotrusion of the knotted cords into the surrounding tissue and avoidsthe unintentional unlocking of the device.

For clarity, a top view of the device is shown in its open (left) andclosed state (right) in FIG. 10C. As can be seen, the cut outs of innerturning member 534 are dislocated from openings 528 529 by turning,thereby wedging the cords 520 between turning member and itscorresponding casing.

In FIG. 10D, a cross section of the device in its open (left) and closed(right) state is shown. As evident, cords 520 can pass freely in theopen state, while they get blocked by inner turning member 519, (whichhas a jagged appearance 537 in this variant of the device) upon lockingof the device.

In one variant, inner fastening member 519 is a screw which facilitatesits introduction into sleeve 522 during assembly. Other designs, e.g.cylindrical structures with jagged outer surfaces are possible as well,as long as the cords get locked upon dislocation of the correspondingcut outs. Moreover, the jagged appearance of the surfaces of the innerfastening member and the sleeve are exemplary only. Rounded structuresmay serve as well in locking the cords by wedging. Cut outs 534corresponding to the sections of openings 528, 529 on inner fasteningmember 519 may be of a shape that the initial turning of the innerturning member is facilitated. FIG. 10E is a bottom view of the device,illustrating open (left) and closed state (right).

In FIG. 11, device 550′ is shown with inserted and knotted cords 520.Grooves 525, along with central depression 524 in fastening member 519assure minimal protrusion of knot 538 into the surrounding tissue regionin a way similar to device 520′.

Devices for Graft Preparation and Fixation Using the Split TendonTechnique

In the following two sections, devices 600, 600′ for the preparation andfixation of grafts are described, which reconstruct the ribbon-likenature of the ligament using the split tendon technique. As an example,the application to the anterior cruciate ligament is again shown.

In contrast to the ligament it should replace, the harvested tendon,which is currently used for reconstruction has a round cross section. Inorder to create a flat, ribbon-like structure, the cylindrical tendonneeds to be incised along its length, preferably to a depth on the orderof half its diameter. Subsequently, the tendon can be unfolded along thecut, whereby the desired ribbon-like morphology is produced. Theincision can be accomplished by a knife, a sharp spoon or any similartool. Longitudinal cutting of the tendon, with minimal destruction ofthe parallel tendon fibres, is essential since this could negativelyinfluence the stability of the graft. Furthermore, the device shouldhave means to avoid completely cutting or splitting of the tendon, sincethis could again negatively influence stability of the graft. Thedevices presented below exemplify the creation and use of ribbon-likestructure from single harvested tendons and are only examples of devicesthat are used.

1) Device for Tendon Splitting

In FIG. 12A-12C, device 600 is presented, which allows the preparationof a flat graft from a cylindrical graft. As exemplified in FIG. 12A,device 600 has base plate 601 with elevated region 615 over which slider604 with attached cutting unit 606 can be moved longitudinally in thedirection of arrow 611. Cylindrical tendon 608 is placed in groove 602of elevated region 615 and fixed distally with yoke 607 crossingelevated region 615. Yoke 607 itself may for instance be fixed at thesides 616 of elevated region 615 for example by screws 603. Cutting unit606 cuts the cylindrical tendon longitudinally when slider 604 is movedalong the base plate. The position of yoke 607 can be adjusted to thelength of the graft (see arrow 610).

The incision can be accomplished by using a knife, sharp spoon oranything the like. A detail of cylindrical graft 608 and cutting unit606 is shown in FIG. 12B. Preferably, cutting of the tendon is performedwith a single use surgical blade 606, which can be attached via astandardized surgical blade adaptor 605. Longitudinal cutting of thetendon with minimal destruction of the parallel tendon fibres isessential since this could negatively influence the stability of thegraft. Furthermore, measuring portions of the device avoid completecutting of the tendon, by providing a stable offset of the cuttingdevice from the base plate.

In another embodiment, exemplified in FIG. 12C, graft 608 is moved inits longitudinal direction through device 600′ with stationary cuttingunit 606. As shown, cylindrical graft 608 slides inside bore 614 instructure 612 which is rigidly connected to mounting 605, 613 of cuttingunit 606. Cutting unit 606 is positioned in a way to allow longitudinalcutting of cylindrical tendon 608 approximately down to its axis 609.The cutting of the tendon can be performed with a single use surgicalblade 606, which can be attached via a standardized surgical bladeadaptor 605.

2) Device for Femoral Fixation of Split Tendon Grafts

Referring now to FIG. 13A a detailed view of device 700 for femoraltendon attachment and fixation using a ribbon-like tendon graft ispresented. The device is a button-like device with elongated body 704holding tape 703. Tape 703 contains elongated window 702. Adjacent towindow 702 is tape area 701, which is utilized for sewing theribbon-like graft to the tape. Furthermore elongated body 704 has twoopenings 705, 706, through which a pulling cord and a tilting cord canbe introduced, similar to the way described in FIG. 7A. Once the tendonis attached to the tape, elongated body 704 of the button-like devicecan be pulled through the bone tunnel, until it exits at theextra-osseous side of the bone. By pulling on the tilting cord, thebutton flips into a direction perpendicular to the bore, thereby beingsecured at the extra-osseous side of the bone. A more detaileddescription of the mode of action may be found in U.S. Pat. No.5,306,301 to Graf, the entire enclosure of which is hereby incorporatedby reference. In contrast to the device presented by Graf et al. in U.S.Pat. No. 5,306,301, the device presented here features a slim tapestructure to avoid bulking of the tendon, when the construct is pulledthrough the femoral and tibial tunnel. Furthermore, it featuresstitching area 701, used for the fixation of the flat tendon in a planarway across its entire width spanning the length of window 702. With thisproceeding, a semi-rigid structure is formed, where the tendon graftcannot slip together, while bending in the transverse direction is stillpossible as shown in FIG. 13B. The possibility of tape area 701 to bendis important, since the tape has first to pass the C-shaped tibialchannel before being drawn into the femoral channel.

The tape-structure of device 700 depicted in FIGS. 13A-13B is exemplaryonly. Other embodiments of the device may employ a stitching areaattached to a loop or a sling. Further variations of loop or tapestructures, which allow a ribbon like attachment of the tendon to thefixation device, are shown in FIG. 13C.

In FIG. 13C (embodiments a.) to d.)), the element holding the tendon isa tape-like structure with window 702 and adjacent stitching area 701 asdescribed above. Appliances linking this structure to elongated body 704may be tape-like 703 or round structures 709, for example cords.Referring now to FIG. 13C, embodiment e.) and f.), the element holdingthe tendon is a structure, where the area 710 over which the tendon isplaced is thickened by additional strands of material to stiffen saidarea and/or provide a stitching area as described above. Applianceslinking structure 710 to elongated body 704 may be round structures, forexample cords, with one 713 or two legs 712.

In FIG. 13C, embodiments g.) and h.), the area over which the tendon isplaced is stiffened by tube 711, which is preferably semi-rigid to allowan easy pulling-in of the structure through the tibial and femoraltunnel. Appliances linking this area to elongated body 704 may be roundstructures, for example cords, with one 713 or two legs 712.

Alternatively, the stitching area is a flag-like structure 755, which isattached to and can move on a cord 750. Preferably, this structure ismade of a textile or a mesh, which has openings at the side or in itscorners, that allows the passing of a suture/cord (FIG. 13C, i.).

Also, a mesh can be bent over the suture and fixed by stitching ormolding the bent mesh in a matrix (e.g. silicone, FIG. 13D, embodimentsb.), c.)), whereby the cord protrudes at each side of the flag (atposition 754). In FIG. 13D, embodiment b.), a mesh 751, which is bentover the cord 750 is shown. In FIG. 13D, embodiment c.), the mesh ismoulded in a matrix 753, which allows a precise modulation of thestiffness of the flag structure by employing different matrices.

3) Device for Tibial Fixation of Split Tendon Grafts

Referring now to FIG. 14A, assembled device 800 for tibial tendonattachment and fixation using a ribbon-like tendon graft is presented.Analogous to the femoral attachment device, the device 800 features tape801 with window 802 and stitching area 803. Fixing device 804 has thepurpose of fixing the tape at the exit of the tibial tunnel. Itcomprises slit 808 designed to let tape 801 pass through. This fixingdevice has an upper and a lower surface and slit 808 is inclined tothese surfaces (see last drawing of FIG. 14B). The tape 801 thereforepasses through fixing device 804 at an angle. Referring now to FIG. 14Bthe extra-osseous element of fixing device 804 for tibial tendonfixation using a ribbon-like tendon graft is depicted in more detail.The first drawing shows the device from above, with inclined slit 808and two adjacent slits 807, 809 which are open on one side. The openingscan be on the same or on opposing sides (as depicted) of device 804. Thesecond drawing shows the device 800 from below. Note that opening 810 ofslit 808 is shifted with respect to that on the upper side. This is dueto the inclination of the slit, visible in greater detail in the lastdrawing of FIG. 14B, where tape and fixing device are both shown. FIG.14C shows a preferred embodiment of tape structure 801. Othervariations, such as a tape with constant width, can be used as well.FIG. 14C shows the preferred embodiment of said tape structure (801),but also variations as described under FIG. 13C can be used with thissystem.

Referring now to FIG. 14D, a series of images depict the process offastening tendon attachment 801 to fixing device 804. In a first step,the tape is pulled to straighten the graft. By pushing down theextra-osseous element (fixing device 804) to the bone adjacent to thetibial tunnel, tape and the extra-osseous element become wedged (due tothe inclination of the slit). This leads to a first fastening of thetape, which can be further enhanced by pulling on the tape. In order tosecure the tape further, the tape is strapped through first adjacentslit 807 and then through second slit 809, Step 2. With this procedure,the tape can be easily adjusted and secured without the use of a knot.Application of knots on cords or tapes (or similar structures) undertension is difficult and in general leads to a loosening of the tension,which is avoided with this procedure.

In general, the flat prepared tendon structure can also secured on thetibial side to device (s) exemplified in FIG. 13C (embodiments c-h) orFIG. 13D, where cords protrude from the various graft fixation means. Inthis case, fixation can be achieved by extra-osseous elements 510′,520′, 530′, 540′ and/or 550′, which fixes the cords coming from thegraft and have been described in more detail in the section describingthe tibial fixation of a multi bundle graft. In a preferred embodiment,the tibial side of a graft prepared from a split tendon is secured bydevice shown in FIG. 13D, embodiment c) and fixed to the tibia byemploying device 550′.

Accessories

In the following description, accessories aiding in the correctplacement of the femoral tunnel and a device intended to allow standardtensioning of the graft during reconstruction surgery are presented.

1) Femoral Aiming Aid

Referring now to FIG. 15A-15D, femoral aiming aid device 900 helps insetting the femoral guide-wire. FIG. 15A is a top view, while FIG. 15Bis a perspective view. The device 900 is positioned at the lateralintercondylar notch wall at the femoral insertion site of the ACL withthe help of two “noses” 901, 902 at its end. The device consists of ahandle 906 with a curved connecting piece 904, 905 and a tip portiondetailed in FIG. 15C. The curvature of connecting piece 904, 905 allowsan easier introduction through an anterolateral arthroscopy portal. Atits tip device 900 has opening 907 for setting a guide wire.Additionally, two noses 901, 902 aid in placing the device at the rightposition of the femur, as depicted in FIG. 15D, where a longitudinal cutthrough the femur 908 with device 900 in place is shown. One “nose” 902is aligned with the posterior aspect of the femoral condyle (see arrow910, FIG. 15D) and the second one 901 with the posterior lateral cortexof the femur (see arrow 911, FIG. 15D). These two “noses” are designedto position the drill guide at the femoral insertion site. There is onedrill guide for the right and left knee. There are also different sizesof drill guides to take into account the different sizes of theindividual insertion sites.

2) Graft Tensioning Device

Referring now to FIGS. 16A-16B, device 10000 allows calibratedtensioning of a graft attached to two cords. Currently, the tensionapplied to grafts used for ACL reconstruction is not standardized andhence subject to high surgeon-specific variation. Furthermore, studies(Biomechanics and anterior cruciate ligament reconstruction, Woo S L etal., J Orthop Surg Res. 2006 Sep. 25; 1:2, the content of which isincorporated herein by reference) have shown, that the tension withinthe ACL varies in the various fiber bundles. A standardized procedure,where the graft can be tensioned taking into account the necessarytension and the distribution of the tension within the graft overcomesthese problems.

FIG. 16A shows a front view of device 10000 with attached graft 1050 andgraft fixation device 1035. FIG. 16A refers exemplarily to the graftfixation device of FIGS. 10A and 11. Graft tensioning device 10000 is,however, applicable to any graft fixation device in which two cords areemployed. As depicted, cords 1040, 1045, coming from the two edges ofgraft 1050, are fed through graft fixation device 1035 and attached tosuspension 1020 on force sensing device 1015 measuring the force appliedto the cords and transmitted to the graft. Here force sensing device1015 is depicted as a spring balance, but every appliance serving thesame function can be used. A force sensing device 1015 is attached toeach one of the two cords coming from the graft. Different tensions canbe applied to each cord by tilting handle 1005 to which the forcesensing devices are attached. When a stronger force is applied to thecord on the left (shown as longer arrow 1060) and a weaker force (shownas shorter arrow 1055) on that on the right by tilting the handle, theleft and right part of graft 1050 are subject to a differential force.It should be noted that the use of a handle facilitates one-handedoperation of the device. By securing the individual cords by themechanism described in FIGS. 10A to 10E and 11, the tension applied tothe graft is locked. Naturally, devices adapted to the use of adifferent number of cords or tapes and corresponding force sensingdevices are variations of device 10000.

Referring now to FIG. 16B, a perspective view (surgeon's view) of thedevice 10000 is shown. As described above, the differential andcalibrated tensioning of the graft can be applied in a one-handedmanner, leaving the other hand free for the actuation of the lockingmechanism of the graft fixation device.

3) Tibial Dilator

Referring now to FIGS. 22A-22D, a perspective view of the tibial dilator1200 is shown. The dilators 1200, which are of same size and shape asthe intended c-shaped tunnel, can be used to compress or dislocateremaining bone structures to achieve the intended graft channels.Therefore, the head 1201 is introduced in the tibial bores with the helpof k-wires 1206. The k-wires 1206 are introduced via holes 1213 (FIG.22C) in the head and in handle 1203 of the dilator. The k-wires can movefreely in head and groves 1207 on the backside of handle 1203 (FIG. 22B)In a first position, the k wires protrude approximately 3-6 cm over thehead of the dilator and the k-wires guide the head through the tibialbores upon introduction of the device until k-wires reach the end of thetibial bores. Upon tapping on the back of the dilator 1208, the dilatormoves along k-wires 1206, which hinder a tilting of the head of thedilator and guide the head through the bores. This is facilitated byslopings 1209 and 1210, which allow a gradual compression of the boresuntil the desired profile 1211 (tibial channel) at its full extent isreached (FIG. 22D).

Consecutively, the dilator is removed from the tibial channel by pullingand tapping on protrusions 1204. This procedure is facilitated byslopings 1212 and 1214, which hinder that the head of the dilator getsstuck upon removal.

4) Femoral Dilator

Referring now to FIGS. 23A-23D, a perspective view of the femoraldilator 1300 (with inserted k-wire) is shown. The dilators 1300, whichare of same size, dimension and shape like the intended slit liketunnel, can be used to compress or dislocate remaining bone structuresto achieve the intended graft channels. Therefore, the head 1302 isintroduced in the femoral bores with the help of a guiding k-wire 1301.The k-wire is set in an earlier procedure during establishment of thefemoral bores and is still in place before the dilation procedurestarts. The back of the k-wire, which is placed in the central bore ofthe femoral bores, is introduced in opening 1307 of head 1302 and thedilator is moved along the axis of the k-wire to the femoral bores. Upontapping on the back 1306 of handle 1304, the dilator moves along k-wire1301, which guides the head through the bores. This is facilitated bysloping 1308, which allows a gradual compression of the bores until thedesired profile 1309 (femoral channel) at its full extend is reached(FIG. 23D).

Consecutively, the dilator is removed from the tibial channel by pullingand tapping on protrusions 1305. This procedure is facilitated bysloping 1310, which hinders that the head of the dilator gets stuck uponremoval.

Methods

In the following description, methods for the anatomically correctreconstruction of ligaments employing flat, ribbon-like grafts will bedescribed. Exemplary, ligament structures within the knee, with specialfocus on the anterior cruciate ligament are addressed. The methods makeuse of the devices for ligament preparation, introduction and fixationdiscussed above. It is appreciated that in one variant of the invention,portions of the graft are positioned to completely span or substantiallyspan the distance “slit like” femoral bone apertures in the femur in theknee joint, while other portions of the graft span the “C-shaped” orhalf-moon shaped apertures in the tibia in the knee joint.

Creation of ACL Insertion Sites

1) Creating the Tibial Insertion Site of the ACL

Referring now to FIG. 17A, flowchart 1100 describes a generic method forcreating the tibial insertion site of the ACL in seven steps. In orderto measure and analyse the length and shape of the insertion site, thetorn ligament is first removed and the insertion site is cleaned fromresidual ligament. As shown in FIG. 1B, the insertion site is a C-shapedor half-moon like structure, with patient specific variations in sizeand curvature. The method addresses the naturally occurring andanatomically correct reconstruction of this structure. Upon havingidentified location, size and orientation of the insertion site, anaiming device is installed. Creation of the C-shaped or bent tunnel canbe accomplished by a bur, chisel or preferably, by multiple drillingtechniques.

By way of example, flowchart 1110 in FIG. 17A describes a method forachieving this structure. With the help of device 200 multiple drillholes are arranged in a manner reflecting the ribbon-like and C-shapednature of the ligament insertion site. Since these bores overlap, acurved slit is created. By using appropriate drill sleeves 207 thetibial tunnel and respectively insertion site can be adjusted to patientspecific anatomy.

2) Creating the Femoral Insertion Site of the ACL

Referring now to FIGS. 17A-17B, flowcharts 1100 and 1100′ describegeneric methods for creating the tibial and femoral insertion sitesrespectively in seven steps. In order to measure and analyse the lengthand shape of the insertion site, the torn ligament is removed and theinsertion site is cleaned from residual ligament.

As shown in FIG. 1C, the insertion site is a straight, ribbon-likestructure, with patient specific variations in length and width. Themethod addresses the anatomically correct reconstruction of thisstructure. Drilling of the slit-like tunnel can be accomplished by usinga bur, chisel or preferably, by creating said structure by multipledrilling with drills representing the width of the insertion site or thetorn ligament, respectively. Exemplary, flowchart 1110′ in FIG. 17B andflowchart 1120′ in FIG. 18B describes a method for achieving thisstructure. With the help of device 300 multiple drill holes are arrangedin a manner that reflects the straight and ribbon-like nature of theligament insertion site. Since these bores overlap, a slit is created.By using appropriate femoral aiming aid 300 the femoral tunnel andrespective insertion site can be adjusted to patient specific anatomy.FIGS. 18A-18B illustrate the creation of tibial tunnel and femoraltunnels in 10 steps in one variant of the invention.

Graft Selection, Preparation and Fixation

Referring now to FIGS. 19A-19B, flowcharts 10120, 10120′ depict genericmethods using components of system 3000 for creating a ribbon-like ACLgraft from either multiple parallel bundles or from split tendons. Inorder to resemble the natural anatomy of the ligament as closely aspossible, multiple ways are possible to create a ribbon-like structurepreferably from a tendon graft.

By way of example, but not exclusively, possible graft donor sites forthe reconstruction of the ACL, and the way in which autografts andallografts can be prepared, are as follows:

1. Hamstrings

To create a flat rectangular shape with hamstring tendons two optionsare possible. (1) A graft made from four strained hamstrings, which, incontrast to common round techniques, is folded in a way in which thetendon strands lay parallel to each other. (FIG. 21A). (2) The secondpossibility is to partially split the round hamstring tendonlongitudinally to create a flat tendon (FIG. 21B). This novel way ofhamstring use allows the creation of tendon shapes, which closelyresemble the “ribbon-shape” ACL.

2. Patellar Tendon

Alternatively, to aligning multiple tendon strands or splitting thetendons, the graft can be carved out of the patellar tendon in a flatand ribbon shaped fashion. Commonly it is harvested with two boneblocks, which are prepared to fit a round bone tunnel. The proposedtechnique employs a small, rectangular bone block, but also uses withouta bone block are possible.

3. Quadriceps Tendon

In the same way, a ribbon shaped part of the quadriceps tendon (QT) canbe carved out of the quadriceps tendon with or without a bone block fromthe patella. Commonly, the QT has been prepared in a round shape with adiameter up to 10 mm. With the proposed technique a 6-8 cm long strip(depending on the use of a bone block) of the central third of the QT isutilized. The strip which is carved out of the quadriceps tendon is 10to 15 mm wide and 4 to 5 mm thick depending on the size of the ACL to bereplaced.

If no bone block is used, a 5-12 mm long portion of the insertion zoneof the quadriceps tendon to the patella can be lifted from the patellaand harvested together with the quadriceps tendon-graft. This (thinner)portion of the graft can be flipped back over the femoral graft fixationmeans to provide a round and smooth edge for pulling in of the graft.With this proceeding a splicing of the graft at the tunnel openings canbe minimized during pulling in of the graft.

4. Synthetic Ligaments

In the same way, the proposed reconstruction method can be performedemploying synthetic ligaments with a flat ribbon-like appearance.

Graft Preparation Using Multiple Parallel Bundles.

Referring now to FIGS. 20A-20B, flowcharts 1130, 1130′ describes amethod of preparing ribbon-like grafts from tendon bundles. Currently,tendon grafts are harvested and multiple bundles of the tendon are sewedtogether in different ways, employing multiple suture techniques. All ofthese suture techniques have in common, that a more or less cylindricalstructure with a round cross section is created, since these grafts areintended to fill the cylindrical bores created with the conventionalreconstruction techniques.

By contrast, the method presented here allows reconstruction of the tornligament with a ribbon-like structure, which is anchored in slit-likebore tunnels. The ribbon-like grafts from tendon-bundles are made bymeans of devices 400 and 500.

Graft Preparation Using the Split-Tendon Technique

Referring now to FIG. 20B, flowchart 1130′ describes a method ofpreparing ribbon-like grafts by using the split-tendon technique. Incontrast to the ligament it should replace, the harvested tendon, whichis currently used for reconstruction has cylindrical shape with a roundcross section. In order to create a flat, ribbon-like structure, thetendon is split by an incision reaching the cylinder axis, andsubsequently unfolded into two connected halves. This incision can beaccomplished by using a knife, sharp spoon or anything the like. In apreferred embodiment device 600 is used to incise the tendon. It allowslongitudinal cutting of the tendon, with minimal damage to the paralleltendon fibres, which could negatively influence the stability of thegraft. The flat tendons are secured by stitching to femoral and tibialfixation means, which allow the upholding of the ribbon shaped nature ofthe graft.

In a variation, the flat and ribbon shaped graft is carved out of atendon (e.g. patella tendon, quadriceps tendon) as a rectangular stripand secured by stitching to femoral and tibial fixation means, whichallow the upholding of the ribbon shaped nature of the graft.

Insertion and Fixation of Ribbon-Like Grafts

Referring now to FIG. 20C, flowchart 1140 describes a method forinserting and fixing a ribbon-like graft in the tibial and femoraltunnel or pocket. In further variants of the invention, a system for theanatomical reconstruction of the anterior cruciate ligament to mimic anaturally occurring ACL in biomechanical function and stability includesdevices selected from a list of devices that include one or more of:aiming device 200 for the creation of the tibial bone tunnel; aimingdevice 300 for the creation of the femoral bone tunnel or pocket;guiding device 900 for positioning a guide wire at the femoral insertionsite; a device for the attachment of ribbon-like grafts to the femoralinsertion site; a device for the attachment of ribbon-like grafts to thetibial insertion site; an optional device 1000 for tensioning the graft;and, devices 500, 600 for preparing flat, ribbon-like grafts.

Aiming device 200 for the creation of the tibial bone tunnel with a bentor C-shaped appearance includes at least one or more portions thereofselected from: an intra-articular portion 203 configured to position andhold a template 206 at an intra-articular insertion site; and, anextra-articular portion 202, holding an extra-articular drill sleeve207, wherein intra- and extra-articular portions are rigidly connected.Aiming device 300 for the creation of a femoral bone tunnel or pocketwith straight, slit-like appearance, includes at least one of thefollowing portions and features thereof: a guiding tube 303 for theaiming of a guide wire; drill channel(s) 304 adjacent to said guidingtube; and, viewport for an arthroscope 307 configured to allowsimultaneous observation of a guide wire and insertion site.

The device for the attachment of ribbon-like grafts to the femoralinsertion site includes a device which includes: device 400 for theattachment of ribbon-like grafts from multiple tendon bundles; and/ordevice 700 for the attachment of ribbon-like grafts from split tendons.The device for the attachment of ribbon-like grafts to the tibialinsertion site includes a device selected from a list of devices, and/orone or more features of the devices described below: a device for theattachment of grafts made from multiple tendon bundles, chosen from alist including: device 510′ comprising a rigid flat body with holes 551,552 for cord insertion and knotting; device 520′ comprising a rigid flatbody with a depression 563 accepting the knot; device 530′ comprising arigid flat body with holes adapted for fastening the inserted cords bywedging before tying a knot device 540′ comprising a rigid flat body 580with a sloped extension 585 with slits 586 permitting knotting andtensioning single cords; and, device 800 for the attachment ofribbon-like grafts made from split tendons. Device 500 is adapted forthe preparation of flat, ribbon-like grafts from multiple tendon bundlesin one variant. In another variant, device 600 is adapted for thepreparation of flat, ribbon-like grafts from split tendons.

Device for the creation of a first bone tunnel has an adaptor for anintra-articular template, whose inner opening represents the bore, whichwill be formed by drilling when the corresponding extra-articulardrill-sleeve will be employed. The adaptor of the intra-articulartemplate features a spike (or similar appliance) for fixing theintra-articular portion of the device to a surface within the joint(e.g. the tibial plateau).

The intra-articular template represents the shape and length of thepatient specific insertion site of the ligament. (e.g. bent, arched orc-shaped for the tibial insertion site of the anterior cruciateligament). The extra-articular drill sleeve corresponds to theintra-articular template in one variant of the invention. Theextra-articular drill sleeve features at least one drill sleeve for theguidance of a driller/bur and at least one guidance tube for aguide-wire. Drill tunnels for guidance of the drills can not only beformed as cylindrical holes, but also segments of cylindrical holes bigenough to guide a drill/bur. The bore(s) created by using the guidancetube for the driller(s)/bur(s) overlap(s) with the bore created afterover drilling of the guide wire. Alternatively, guidance tubes for thedrill/bur can be of an elongated and bent cross-section, along which abur or drill can be moved to form a slit-like opening in the bone.

The extra-articular portion of the aiming device features a holder forthe drill-sleeve, which can be moved along the drill-axis and be lockedwith a screw or similar device. The holder of the drill sleeve can fixthe drill-sleeve by slight compression of the drill sleeve or a similaraction. The extra-articular drill sleeve may feature at least one tube(preferably slotted), through which a spike/guide-wire can be movedalong the drill axis, which is used to stabilize the extra-articularportion of the device to bone. The spike(s)/guide-wire(s) (which is/areintended to stabilize the extra-articular portion of the device to bone)in the drill sleeve can be fixed by slight compression of the drillsleeve or a similar action. The spike(s)/guide-wire (s) (which is/areintended to stabilize the extra-articular portion of the device to bone)is/are part of the extra-articular drill sleeve holder.

The device for the creation of a second bone tunnel has at least onedrill sleeve for the guidance of a driller/bur and at least one guidancetube for a guide-wire. The bores created with the device represent theshape and length of the patient specific insertion site of the ligament.(e.g. straight and ribbon like at the femoral insertion site of theanterior cruciate ligament). Drill tunnels for guidance of the drillscan be formed not only as cylindrical holes, but also segments ofcylindrical holes big enough to guide a drill/bur. The depth of thebores can be controlled by reading the depth marks of the driller at theedge of the bore sleeve before and during drilling. The device can beused to perform drilling through the whole bone to form a uniform tunnelOR can be used to create a pocket in the bone. The device can be used tocreate a pocket in the bone with a (central) tunnel, which reaches theother cortex of the bone, thereby minimizing the damage to the bone. Thebore(s) created by using the guidance tube for the driller(s)/bur(s)overlap(s) with the bore created after over drilling of the guide wire.Alternatively, guidance tubes for the drill/bur can be of elongatedcross-section, along which a bur or drill can be moved to form aslit-like opening in the bone.

The device features a view-port for an arthroscope, which allows directvisualization of the tip of the guide-wire and the graft insertion site.

The guide-wire is equipped with a removable stamping adaptor, which canbe used to transiently fix the guide-wire by tapping or pushing on thestamping adaptor in the longitudinal direction of the guide-wire. Theguiding device for the right allocation of the femoral bone tunnelfeatures a bent handle to ease the access to the femoral insertion sitein an arthroscopic setting. Furthermore, it features two “noses” foralignment of the device with the posterior aspect of the femoral condyleand with the posterior lateral cortex of the femur.

A system for the ribbon-like attachment of multiple tendon bundlesincludes one or more of the following devices and/or features thereof: abutton like device for the mounting and fixation of multiple bundletendon grafts; a device for the alignment of individual bundles using a“weaving-technique”; and, a device for fixing a ribbon-like tendon graftwith at least two cords.

The button-like device has an elongated body 607, which holds a sling orloop 601, which is subdivided by at least one partitioning 605. Thepartitioning can be either fixed 605 or can move along the sling orloop, as exemplified in FIG. 12C. The strands of the tendons form alinear alignment, where the upper strand is held apart by the lowerstrand of the tendon. Alternately, the strands of the tendons form alinear, semi-rigid structure of the individual tendon bundles, whichstill can be bent transversally. The strands of the tendons form alinear, semi rigid structure of the individual tendon bundles, whichstill can be passed through a non-linear (e.g. C-shaped) bone tunnel.

The pushing together of the individual tendon bundles is hindered by asequential pulling in, which favours a smooth pulling in of the graft,especially in slit-like bone tunnels with a small width. The device forthe alignment of individual bundles using a “weaving-technique” featuresa base-plate with holes 505, which are connected with slits 506. Thepulling ends of a cord (or the like, 501 and 502) as well as the loops503 are on the front side of the base plate, while the connectingsections of the cord are on the backside of the base plate. The size ofthe holes is large enough to allow passing of a cord or suture-material501,502, while the slits are more narrow and allow the passing of thecord only when force is applied to the cord and the walls of the slitsare dilated.

A linear mounting for the opposing side of a multi-bundle graft isformed, where the individual strands are pressed together, but cannotslip over each other, thereby eliminating the formation of a bulkygraft. This is especially important in the case where slit-like tunnelswith a small width are employed. The cord slips through the slits of thebase plate if enough force is applied, and the linear tendon/cordconstruct is released from the base plate.

The device for fixing a graft with two cords has a flat rigid body,which is larger than the created bone tunnels and has two openings toaccept the two cords, which are attached to the graft. The flat rigidbody has a deepening or grooves with two openings, which accepts theknot after knotting of the two cords, which are attached to the graft.The openings are narrower to the center of the device to allow a wedgingtogether of the cords before knotting. The cords can be tensioned afterknotting by pulling them over a slope to a securing position moredistant from the graft. The cords can be tensioned optionally.Alternatively, the cords can be tensioned and fixed by graft fixationmeans exemplified in FIG. 10A. The device for fixing a graft with twocords has a flat rigid body with sleeve and rotation of an innerfastening member results in displacing cut outs from the openings in thesleeve, whereby the cords are compressed between the jagged innerfastening member and wall of the sleeve.

A system for the ribbon-like attachment of a flat split-tendon includesone or more of the following devices and features thereof: a button-likedevice for the mounting and fixation of a flat split-tendon graft; abuckle-like device for the mounting and fixation of a flat split-tendongraft; and/or a device for preparing a flat tendon graft out of acylindrical tendon graft.

The button-like device has an elongated body (607), which holds a tapesling or loop, which has an opening with an adjacent stitching area. Thestitching area is used for the fixation of the flat tendon in a planarway by securing the edges and the mid of the tendon over the distance ofthe opening. A semi-rigid structure is formed, where the tendon graftcannot slip together, but a transversal bending is still possible asshown in FIG. 13B.

The buckle like device for the mounting and fixation of a flatsplit-tendon graft features a tape-like structure (801) with an openingand stitching area. The tape-like structure is fastened and fixed withan extra-osseous element at the exit of the bone tunnel by passing thetape through a slit in the buckle-like device. The buckle-like devicefeatures at least one adjacent slit, which can be open on one side (807and 809) or closed. The buckle-like device features preferably twoadjacent slits (807 and 809) which are open on one side or on oppositesides. The buckle-like device features an angulated slit, preferably inan angulation that the tape and the extra-osseous element become wedgedtogether, when tension is applied to the tape and the extra-osseouselement is locked at the exit of the bone tunnel.

The tension of the tape (and consequently the graft) can be furtheradjusted by pulling of the tape and a first fastening of the tape isaccomplished by the mechanism described herein. The tape can be furtherSecured by strapping back in a first adjacent slit (807) and then to asecond slit. The application of knots for the fixation of graftstructures under tension is avoided and therefore a loosening of thetension of the cord/tape is omitted with this proceeding. The tapewithout the buckle-like device can be secured by introduction of ascrew, which presses the tape towards the bone-tunnel wall.

In general, the flat prepared tendon structure can also be secured onthe tibial side to device (s) exemplified in FIG. 13C (embodiments c-h)or FIG. 13D, where cords protrude from the various graft fixation means.In this case, fixation can be achieved by an extra-osseous element 510′,520′, 530′, 540′ and/or 550′, which fixes the cords coming from thegraft and have been described in more detail in the section describingthe tibial fixation of a multi bundle graft. In a preferred embodiment,the tibial side of a graft prepared from a split tendon is secured bydevice shown in FIG. 13D (embodiment c) and fixed to the tibia byemploying device 550′.

A flat tendon graft is prepared from a cylindrical graft by longitudinalsplitting. A cylindrical graft is placed in a device, such as that shownin FIGS. 12A-12C, which cuts the cylindrical graft to its approximatedmiddle portion, thereby allowing an unfolding of the cylindrical graftto a flat structure. The device may include precautionary measures ormeasurement points, which avoid total cutting or splitting of the graft,such as a set maximum penetration into the cutting canal 602.

The device features standardized adaptors for conventional surgicalblades. A cylindrical graft is placed in a device, which fixes the grafton its distant side and has a slide with an attached cutting device,which moves longitudinal to the inserted graft, thereby cutting thegraft in its longitudinal direction. The cylindrical graft is placed ina device with a fixed cutting device and the graft is pulled through thedevice and is cut in its longitudinal direction.

A method for creation of bone tunnels representing the insertion site ofa ligament structure (e.g. the anterior cruciate ligament) includes thefollowing steps: performing the measurement of the insertion sites (e.g.tibial and femoral); choosing the location and orientation of theinsertion sites (e.g. tibial and femoral); positioning of an aimingdevice(s) over the chosen location(s); creating tunnels OR incompletedrilling/burring of said bores to create a pocket-like structure in thebone, which resembles the insertion site or naturally occurringfootprint of the ligament attachment point. (Half-moon or C-shaped atthe tibial insertion site and straight and ribbon shaped at the femoralattachment site); removing the aiming device(s); and, optionallycleaning of the edges by using a drill, bur, rasp, chisel, knife orsimilar device.

A method of multi-bundle tendon preparation, which results in aribbon-like structure to reconstruct a ligament is also included in theinvention. The method including the steps of: harvesting the tendon tobe used for the tendon preparation; preparing the graft, which allowsthe mounting and fixation of the tendon in a way that the individualstrands are arranged in a ribbon-like, flat fashion; and, preparing theindividual strands of the graft in a linear arrangement on the oppositeside of the graft.

The invention includes another variant in which a method of a flattendon preparation and attachment, which results in a ribbon-likestructure to reconstruct a ligament. The method including the steps of:harvesting the tendon to be used for tendon preparation; preparing theround tendon structure into a flat, ribbon-like structure by cutting orblunt incising along the longitudinal axis of the tendon following thetendon fibres; attaching the flat tendon to a structure, which allows aspanning of the flat tendon orthogonally (or near orthogonal) to itslongitudinal axis; attaching of the opposite side of the flat tendon toa device, which allows the spanning of the flat tendon orthogonally (ornear orthogonal) to its longitudinal axis; and, fixing the flat tendonin both slit-like straight or bent bone tunnels. Alternatively, flat,ribbon-like grafts can be made by carving portions (strips) out of abigger tendon (e.g. patella tendon, quadriceps tendon).

Graft Fixation Using the Split Tendon Technique

In yet another variant, a method of multi-bundle tendon preparation,which results in a ribbon-like structure to reconstruct a ligament isdescribed in the invention. The method including the steps of:harvesting the tendon to be used for the tendon preparation; preparingthe graft, which allows the mounting and fixation of the tendon in a waythat the individual strands are arranged in a ribbon like, flat fashion;and, preparing the individual strands of the graft in a lineararrangement on the opposite side of the graft.

In yet another variant, a method of a flat tendon preparation andattachment, which results in a ribbon-like structure to reconstruct aligament, is described herein. The method includes the steps of:harvesting the tendon to be used for tendon preparation; preparing theround tendon structure into a flat, ribbon-like structure by cutting orblunt incising along the longitudinal axis of the tendon following thetendon fibres; attaching the flat tendon to a structure, which allows aspanning of the flat tendon orthogonally (or near orthogonal) to itslongitudinal axis; attaching of the opposite side of the flat tendon toa device, which allows the spanning of the flat tendon orthogonally (ornear orthogonal) to its longitudinal axis; and, fixing the flat tendonin both slit-like straight or bent bone tunnels.

FIG. 24 illustrates an overall system 3000 architecture view andcomponents of system with exemplary system devices 200, 400, 500, 550described herein (of course, additional devices described herein arealso used in variants of the invention and incorporated into system 3000where desired), and in which a plurality of the system 3000 devicesdescribed herein are used in various combinations. It is appreciatedthat all of the system 3000 devices described herein are used in variouscombinations to enable the system and methods described herein. It isappreciated that one or a plurality of the devices are used in system3000 to achieve the stated purposes of reconstructing a portion of aknee joint with a torn anterior cruciate ligament using a graft, whereinthe graft having a first end and a second end, and whereby naturallyoccurring attachment footprints of a native ACL are mimicked to providebiomechanical stability to the knee joint.

As illustrated in FIGS. 2A-20C, 22A-23D, the invention provides a systemand methods for preparing a first and second bone for a graft procedure.The system includes a device for creating on the first bone an entrancepoint mimicking a first native ligament attachment footprint (1002 FIG.1B), the first native ligament insertion site 1000 optionally being asubstantially half-moon shaped footprint 1002, the device (200, 200′,FIGS. 2A and 4C) having an appliance for sequential drilling or burringof overlapping bores, which are arranged in a c-shaped manner to createsaid c-shaped insertion site; and a device (300, FIGS. 5A-6C) forcreating on the second bone an entrance point mimicking a second nativeligament attachment footprint 1102, the second native ligamentattachment footprint 1102 optionally being a substantially slit shapedfootprint, the device (300) having an appliance for sequential drillingor burring of overlapping bores, the bores being arranged in aslit-shaped manner to create a slit-shaped insertion site, theslit-shaped insertion site substantially conforming in size to acorresponding aperture created with the first device.

As shown in FIGS. 20A-20B, the system and method further includes athird device for creating a substantially ribbon-like ACL graft, saidgraft having a first end and a second end, the device selected from agroup consisting of a device for creating a substantially ribbon-likeACL graft, said graft having a first end and a second end, a devicehaving an appliance allowing to maintain the ribbon-like appearance ofthe graft by affixing parallel tendon bundles or affixing tendons whichare split and prepared in a way to give a flat, ribbon like appearance,and a device for affixing portions of a tendon which have been preparedto give a substantially flat and ribbon like appearance, and optionally,includes a device for fixing at least a portion of the first end of thegraft at a tibial anchor point, the device having a flat structureattached to a mechanism, the mechanism allowing immobilization of theattached graft by wedging and blocking of the attached fixation means.

As shown in FIGS. 9A-9D, the system and method also include devices 510′to 540′ for fixing at least a portion of the second end of the graft ina femoral anchor point, the device having a button-like device for theextra-osseous fixation of the graft, the graft being connected to anappliance, the appliance allowing the affixing of a substantially flatgraft to a flat structure on the fifth device by attaching the graft tosaid flat structure, the flat structure being flexible enough to firstpass through a c-shaped bone tunnel and second through said slit-shapedbone tunnel.

In another variant and as shown in FIGS. 8A-8I, the invention provides agraft and a method for creating a graft for ACL reconstruction. Thegraft includes a first portion which is shaped and dimensioned tosubstantially conform to a slit shaped bone entrance point. A secondportion is shaped and dimensioned to be substantially ribbon like, and athird portion which is shaped and dimensioned to substantially conformto a C-shaped bone entrance point. The system is used in a method forcreating a graft for ACL reconstruction and the system includes a devicefor making the graft as described herein.

As shown in FIGS. 24, 17A-18B and the other figures herein, the system3000 and method is used for reconstructing a portion of a knee jointwith a torn anterior cruciate ligament using a graft. The graft has afirst end and a second end. It is appreciated that the naturallyoccurring attachment footprints of a native ACL are mimicked to providebiomechanical stability to the knee joint. The system includes a firstimmobilizer having a flat structure attached to a button-like device forthe extra-osseous fixation of the graft, the first immobilizer forpositioning and use at a portion of the first end of the graft in, oroptionally on a femur, at least a portion of the graft adapted forpassing through a substantially slit shaped aperture on the femur. Alsoprovided is a second immobilizer having a flat structure attached to amechanism, the mechanism allowing immobilization of the attached graftby wedging and blocking of the attached fixation means.

The second immobilizer is used for positioning and use at a portion ofthe second end of the graft in, or optionally on a tibia, wherein atleast a portion of the graft is adapted to pass through a substantiallyC-shaped aperture on the tibia.

In another variant, the invention provides a method of reconstructing aknee joint with an anterior cruciate ligament tear using a graft. Thegraft has a first end and a second end. The method includes the stepsof: immobilizing a first end of the graft on a femur, at least a portionof the graft passing through a substantially slit shaped aperture on thefemur; immobilizing a second end of the graft on a tibia, at least aportion of the graft passing through a substantially C-shaped apertureon the tibia; and affixing the ends of the graft on their respectiveinsertion sites in a manner mimicking naturally occurring attachmentinsertion sites of a native ACL, in order to provide biomechanicalstability to the knee joint.

In another variant, the invention provides a system 3000 and method(FIGS. 17A-18B) of providing substantially equal biomechanical stabilityfor a bipedal mammal. The bipedal mammal has a native ACL in a firstknee joint and a torn ACL in a second knee joint in the clinicalsetting. The method includes reconstructing the torn ACL in the secondknee joint to obtain a reconstructed ACL, the reconstructed ACLincluding a first portion of a graft passing through a substantiallyslit-like aperture in a first bone, and a second portion of the graftpassing through a substantially C-shaped aperture in a second bone;affixing the ends of the graft on their respective insertion sites in amanner mimicking naturally occurring attachment insertion sites of anative ACL, in order to provide biomechanical stability to the kneejoint; and, allowing for healing with physiotherapy and supervisedrecovery, whereby thereafter, the biomechanical stability of the firstknee joint is substantially similar to the biomechanical stability ofthe second knee joint.

In yet a further variant and as illustrated in FIGS. 24, 17A-17B, theinvention includes a system 300 and method of providing substantiallyequal biomechanical stability for a bipedal mammal having a native ACLin a first knee joint and torn ACL in a second knee joint, whereby afterhealing, the biomechanical stability of the knee joints aresubstantially similar, the method comprising the steps of: forming agraft of an anatomically correct reconstructed ACL; forming an ACLfootprint mimicking a native ACL footprint in the second knee joint;passing a first portion of the graft that passes through a substantiallyslit-like aperture in a first bone; passing a second portion of thegraft through a substantially C-shaped aperture in a second bone;affixing the ends of the graft on their respective insertion sites in amanner mimicking naturally occurring attachment insertion sites of anative ACL, in order to provide biomechanical stability to the kneejoint; and allowing for healing with physiotherapy and supervisedrecovery, whereby thereafter, the biomechanical stability of the firstknee joint is substantially similar to the biomechanical stability ofthe second knee joint.

In yet another variant and as illustrated in FIGS. 2A-2C, the inventionincludes a system 300 method of preparing a tibia for an anatomicallycorrect ACL reconstruction using various devices forming a part ofsystem 3000, including devices 200 and 200′. The method includescleaning and identifying a tibial ACL footprint; measuring the tibialACL footprint with a template; locating and orienting a tibial insertionsite; positioning a tibial aiming device; drilling a bone tunnel, oroptionally a pocket, correlated to the tibial insertion site in asubstantially C-shaped configuration; removing the tibial aiming device;and, optionally cleaning drilling edges.

In yet further variant and as illustrated in FIGS. 5A-5D, the inventionprovides a system 3000 and method of preparing a femur bone for ananatomically correct ACL reconstruction. The method includes the stepsof: cleaning and identifying a femoral ACL footprint; measuring thefemoral ACL footprint with a template; locating and orienting a femoralinsertion site; positioning a femoral aiming device; drilling a bonetunnel, or optionally a pocket, correlated with the femoral insertionsite in a substantially slit shaped configuration; removing the femoralaiming device; and optionally cleaning drilling edges. Device 300 isused in the system 3000 and method in this variant of the invention.

The invention provides a system 3000, devices forming the system, and amethod of creating a tibial bone tunnel during a ligament reconstructionsurgery, comprising the steps of: cleaning and identifying a tibialfootprint; measuring a tibial footprint with a template; attaching oradjusting an intra-articular template to a tibial guiding device;attaching or adjusting a corresponding drill sleeve to the tibialguiding device; drilling to provide a guide-wire or a drill whichstabilises the tibial guiding device; orienting the tibial guidingdevice; drilling adjacent bores or adjacent k-wires in case where adrill was set to stabilise the tibial guiding device; removing thetibial guiding device; drilling a bore over the guide-wire or adjacentguide wires; and, optionally cleaning drilling edges.

In yet further variant, the invention provides a system 3000, deviceswhich are included in system 3000 and a method of creating a femoralbone tunnel, comprising the steps of: cleaning and identifying a femoralfootprint; measuring a femoral footprint with a template; introducing ak-wire with a stamping device with a corresponding femoral guidingdevice; setting the k-wire using an aiming template and an arthroscope;drilling to provide a guide-wire or a drill which stabilises the femoralguiding device; orienting the femoral guiding device; drilling adjacentbores or adjacent k-wires in case where a drill was set to stabilise thefemoral guiding device; removing the femoral guiding device; drilling abore over the guide-wire; and, optionally cleaning drilling edges.

In yet another variant, the invention provides a method of preparing agraft for a ligament reconstruction procedure, comprising the steps of:harvesting a tendon; cleaning the tendon; arranging individual tendonstrands in a substantially ribbon-like, flat manner to mount and fixatethe tendon; and, preparing the individual tendon strands in a lineararrangement.

In yet further variant, the invention provides a system 3000, anddevices used in the system and forming the system 3000, and a method ofpreparing a graft for a ligament reconstruction procedure, comprisingthe steps of: harvesting a tendon to obtain a round tendon structure;cleaning the round tendon structure; preparing a substantially flat,ribbon-like structure from the round tendon structure along alongitudinal axis of the round tendon structure following tendon fibers,the substantially flat, ribbon-like structure having a first side and asecond side; spanning the first side of the substantially flat,ribbon-like structure substantially orthogonally to the longitudinalaxis of the substantially flat, ribbon-like structure by attaching thesubstantially flat, ribbon-like to an attachment structure; and,spanning the second side of the substantially flat, ribbon-likestructure substantially orthogonally to the longitudinal axis byattaching the substantially flat, ribbon-like to an attachmentstructure.

In yet further variant, the invention provides a method of preparing agraft for a reconstruction procedure, comprising the steps of:harvesting a tendon having a plurality of tendon strands; cleaning thetendon; providing a split-button device having a lower partition and anupper partition; introducing the tendon into the lower partition;introducing the tendon into the upper partition; providing a fiber-podhaving separate fields and loops; laying each tendon strand in aseparate field; weaving the plurality of tendon strands through theloops with a plurality of pull chords; tightening the tendon strands bypulling the pull chords; and, optionally securing the tendon strandswith sutures.

The invention provides a system 3000, devices within system 3000, and amethod of preparing a graft for a procedure, comprising the steps of:harvesting a flat, ribbon-like portion of a tendon (e.g. patella orquadriceps tendon); cleaning the tendon portion, preparing asubstantially flat tendon structure; and attaching said structure tofixation means allowing the upholding of a flat appearance of the graft.

In yet further variant of the invention, it provides a system 3000 (FIG.24) in which the system is used to execute a method of reconstructing aligament using a first bone tunnel and a second bone tunnel, comprisingthe steps of: creating the first bone tunnel according to a first nativeligament insertion site; creating a second bone tunnel according to asecond native ligament insertion site; preparing a substantiallyribbon-like, flat graft, the graft having a first end and a second end;pulling in the graft via the first bone tunnel into the second bonetunnel; fixing a portion of the first end of the graft in the secondbone tunnel; tightening and fastening the graft; and, fixing a portionof the second end of the graft in the first bone tunnel. In this variantof the method the first bone tunnel is a tibial bone tunnel, and thesecond bone tunnel is a femoral bone.

It should be appreciated that the particular implementations shown andherein described are representative of the invention and its best modeand are not intended to limit the scope of the present invention in anyway. Moreover, the system contemplates the use, sale and/or distributionof any goods, services or information having similar functionalitydescribed herein.

The specification and figures should be considered in an illustrativemanner, rather than a restrictive one, and all modifications describedherein are intended to be included within the scope of the inventionclaimed. Accordingly, the scope of the invention should be determined bythe appended claims (as they currently exist or as later amended oradded, and their legal equivalents) rather than by merely the examplesdescribed above. Steps recited in any method or process claims, unlessotherwise expressly stated, may be executed in any order and are notlimited to the specific order presented in any claim. Further, theelements and/or components recited in apparatus claims may be assembledor otherwise functionally configured in a variety of permutations toproduce substantially the same result as the present invention.Consequently, the invention should not be interpreted as being limitedto the specific configuration recited in the claims. Benefits, otheradvantages and solutions mentioned herein are not to be construed ascritical, required or essential features or components of any or all theclaims.

As used herein, the terms “comprises”, “comprising”, or variationsthereof, are intended to refer to a non-exclusive listing of elements,such that any apparatus, process, method, article, or composition of theinvention that comprises a list of elements that does not include onlythose elements recited, but may also include other elements described inthe instant specification. Unless otherwise explicitly stated, the useof the term “consisting” or “consisting of” or “consisting essentiallyof” is not intended to limit the scope of the invention to theenumerated elements named thereafter, unless otherwise indicated. Othercombinations and/or modifications of the above-described elements,materials or structures used in the practice of the present inventionmay be varied or adapted by the skilled artisan to other designs withoutdeparting from the general principles of the invention.

The patents and articles mentioned above are hereby incorporated byreference herein, unless otherwise noted, to the extent that the sameare not inconsistent with this disclosure.

Other characteristics and modes of execution of the invention aredescribed in the appended claims. Further, the invention should beconsidered as comprising all possible combinations of every featuredescribed in the instant specification, appended claims, and/or drawingfigures, which may be considered new, inventive and industriallyapplicable.

Additional features and functionality of the invention are described inthe claims appended hereto. Such claims are hereby incorporated in theirentirety by reference thereto in this specification and should beconsidered as part of the application as filed.

Multiple variations and modifications are possible in the embodiments ofthe invention described here. Although certain illustrative embodimentsof the invention have been shown and described here, a wide range ofchanges, modifications, and substitutions is contemplated in theforegoing disclosure. While the above description contains many specificdetails, these should not be construed as limitations on the scope ofthe invention, but rather exemplify one or another preferred embodimentthereof. In some instances, some features of the present invention maybe employed without a corresponding use of the other features.Accordingly, it is appropriate that the foregoing description beconstrued broadly and understood as being illustrative only, the spiritand scope of the invention being limited only by the claims whichultimately issue in this application.

1.-19. (canceled)
 20. A system for creating a graft for ACLreconstruction, the system comprising a device for making the graft forACL reconstruction, the graft comprising a first portion which is shapedand dimensioned to substantially conform to a slit shaped bone entrancepoint, a second portion that is shaped and dimensioned to besubstantially ribbon like, and a third portion which is shaped anddimensioned to substantially conform to a half-moon shaped aperture. 21.A method of preparing the graft of claim 20 for a ligamentreconstruction procedure, comprising the steps of: harvesting a tendon;cleaning the tendon; arranging individual tendon strands in asubstantially ribbon-like, flat manner to mount and fixate the tendon;and, preparing the individual tendon strands in a linear arrangement.22. A method of preparing the graft of claim 20 for a ligamentreconstruction procedure, comprising the steps of: harvesting a tendonto obtain a round tendon structure; cleaning the round tendon structure;preparing a substantially flat, ribbon-like structure from the roundtendon structure along a longitudinal axis of the round tendon structurefollowing tendon fibers, the substantially flat, ribbon-like structurehaving a first side and a second side; spanning the first side of thesubstantially flat, ribbon-like structure substantially orthogonally tothe longitudinal axis of the substantially flat, ribbon-like structureby attaching the substantially flat, ribbon-like to an attachmentstructure; and, spanning the second side of the substantially flat,ribbon-like structure substantially orthogonally to the longitudinalaxis by attaching the substantially flat, ribbon-like to an


23. A method of preparing the graft of claim 20 for a reconstructionprocedure, comprising the steps of: harvesting a tendon having aplurality of tendon strands; cleaning the tendon; providing asplit-button device having a lower partition and an upper partition;introducing the tendon into the lower partition; introducing the tendoninto the upper partition; providing a fiber-pod having separate fieldsand loops; laying each tendon strand in a separate field; weaving theplurality of tendon strands through the loops with a plurality of pullchords; tightening the tendon strands by pulling the pull chords; and,optionally securing the tendon strands with sutures.
 24. A method ofpreparing the graft of claim 20 for a procedure, comprising the stepsof: harvesting a flat, ribbon-like portion of a tendon (e.g. patella orquadriceps tendon); cleaning the tendon portion; preparing asubstantially flat tendon structure; and, attaching said structure tofixation means allowing the upholding of a flat appearance and structureof the graft.